MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 5/170/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366836

Device Problems Fracture (1260); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

Ous mdr- as half of the stent was released, the handle broke and the rest of the stent could not be released.The stent fractured in two parts.Half of the stent remained inside the patient and the other half was retrieved using a cordis support catheter.

Manufacturer Narrative

A technical analysis of the returned instrument was conducted and are view of the manufacturing history was performed to evaluate whether there was any deviation that could account for the reported event.The instrument under complaint was returned completely disassembled with the inner and outer shaft separated.Several kinks were observed in both shafts.An approximately 1.5 cm long fragment of the stent was returned.The outer shaft, which has to be retracted in order to release the stent, was most likely fractured inside the handle.The inner shaft was found ruptured approximately 3 mm distal to the metal tube where the knife is mounted on.Based on the conducted investigations no manufacturing or material related root cause could be identified.The blockage of the stent is most likely related to uncommonly high friction between the stent and the retractable outer shaft.

• Brand Name: PULSAR-18 5/170/135
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• MDR Report Key: 8102228
• MDR Text Key: 128289049
• Report Number: 1028232-2018-04051
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 366836
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10175732
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1