Model Number TSK85-32-BD-71S |
Device Problems
Difficult to Insert (1316); Defective Device (2588)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 06/26/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported that during a percutaneous catheter myocardial ablation procedure to treat atrial fibrillation (a fib) in right inguinal area, a sureflex steerable guiding sheath was selected for use.When the sureflex was tried to be inserted, the tip of the sheath got lifted and the bleeding continued from the side of the sheath.This occurred just below the right inguinal region.It was not advanced deep in the anatomy.There was slight difficulty removing the sheath.The bleeding was stopped with a non-boston scientific device.A new sureflex was used to perform a new puncture.The procedure was completed successfully, and no patient complications occurred.The device is expected to be returned for analysis.
|
|
Manufacturer Narrative
|
The device was returned for analysis.Analysis of the device found the complaint could not be recreated on a top-bench model; therefore, the potential root cause of the complaint cannot be conclusively determined.From the information provided in the complaint summary and testing on the returned product, it is highly unlikely that the sheath left our facility with sheath tip damage since all sheaths undergo 100 percentage visual inspection.The most likely root cause is excessive force applied to patient anatomy by device.There is no evidence to suggest the device did not meet specifications as per testing.The reported allegation is confirmed since the sheath was shown to be deformed through returned product and media.Based on the root cause of the complaint, the failure to follow instructions code was selected.The ifu states do not use excessive force to advance or withdraw the device in dhf tss 5.1a.In addition, the sheath tip was shown to meet specifications.
|
|
Event Description
|
It was reported that during a percutaneous catheter myocardial ablation procedure to treat atrial fibrillation (a fib) in right inguinal area, a sureflex steerable guiding sheath was selected for use.When the sureflex was tried to be inserted, the tip of the sheath got lifted and the bleeding continued from the side of the sheath.This occurred just below the right inguinal region.It was not advanced deep in the anatomy.There was slight difficulty removing the sheath.The bleeding was stopped with a non-boston scientific device.A new sureflex was used to perform a new puncture.The procedure was completed successfully, and no patient complications occurred.The device is expected to be returned for analysis.
|
|
Search Alerts/Recalls
|