Material Failure of Silicone Catheter Lines: A Retrospective Review of Partial and Complete Ruptures in 553 Patients

TY - JOUR

T1 - Material Failure of Silicone Catheter Lines: A Retrospective Review of Partial and Complete Ruptures in 553 Patients

AU - Busch, Jasmin D

AU - Vens, Maren

AU - Herrmann, Jochen

AU - Adam, Gerhard

AU - Ittrich, Harald

PY - 2017/2

Y1 - 2017/2

N2 - OBJECTIVE: This present study reports the frequency and outcome of material failure of the silicone catheter lines of a port device implanted in the upper arm during a 5-year period.MATERIALS AND METHODS: From 2006 to 2011, a total of 553 patients had a port device implanted percutaneously in the upper arm. In the spring of 2013, several instances of material failure led to device withdrawal. At that time, 39 patients (7.1%) with the specific device in situ were still alive, and 36 of these patients agreed to removal. Linear mixed-effects models were used to analyze the log-transformed device dwell time. Random effects were modeled using group variables. The mean estimated values and their corresponding 95% CIs were reported. Nominal p values were reported, and two-sided p < 0.05 was considered to denote statistical significance.RESULTS: Among the 553 patients, material failure was noticed in 19 patients (3.4%), with a mean estimated dwell time of 243 days (95% CI, 104-570 days). Specifically, complete rupture occurred in 10 patients (1.8%) after a mean of 322 days (95% CI, 95-1089 days), partial rupture occurred in eight patients (1.4%) after a mean of 190 days (95% CI, 61-596 days), and disconnection occurred in one patient (0.2%) 8 days after device placement.CONCLUSION: The frequency of catheter line rupture was 3.4%. The mean estimated interval to rupture was less than a year, with an increasing probability of rupture noted in association with a longer dwell time. The exact cause of material failure remains unexplained, and further investigation of the mechanical properties contributing to rupture is required. Insight into the safety profile of these devices is needed to avoid potentially severe injury and improve the management of affected patients.

AB - OBJECTIVE: This present study reports the frequency and outcome of material failure of the silicone catheter lines of a port device implanted in the upper arm during a 5-year period.MATERIALS AND METHODS: From 2006 to 2011, a total of 553 patients had a port device implanted percutaneously in the upper arm. In the spring of 2013, several instances of material failure led to device withdrawal. At that time, 39 patients (7.1%) with the specific device in situ were still alive, and 36 of these patients agreed to removal. Linear mixed-effects models were used to analyze the log-transformed device dwell time. Random effects were modeled using group variables. The mean estimated values and their corresponding 95% CIs were reported. Nominal p values were reported, and two-sided p < 0.05 was considered to denote statistical significance.RESULTS: Among the 553 patients, material failure was noticed in 19 patients (3.4%), with a mean estimated dwell time of 243 days (95% CI, 104-570 days). Specifically, complete rupture occurred in 10 patients (1.8%) after a mean of 322 days (95% CI, 95-1089 days), partial rupture occurred in eight patients (1.4%) after a mean of 190 days (95% CI, 61-596 days), and disconnection occurred in one patient (0.2%) 8 days after device placement.CONCLUSION: The frequency of catheter line rupture was 3.4%. The mean estimated interval to rupture was less than a year, with an increasing probability of rupture noted in association with a longer dwell time. The exact cause of material failure remains unexplained, and further investigation of the mechanical properties contributing to rupture is required. Insight into the safety profile of these devices is needed to avoid potentially severe injury and improve the management of affected patients.

U2 - 10.2214/AJR.16.16540

DO - 10.2214/AJR.16.16540

M3 - SCORING: Journal article

C2 - 27824502

VL - 208

SP - 464

EP - 469

JO - AM J ROENTGENOL

JF - AM J ROENTGENOL

SN - 0361-803X

IS - 2

ER -