MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/20/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 430447

Device Problem Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

A pulsar-18 t3 peripheral stent system was chosen for treatment of a moderately calcified lesion in the sfa.It was not possible to release the pulsar-18 t3 stent.

Manufacturer Narrative

The returned instrument was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the outer shaft has been retracted by about 1 mm, but the stent has not been released.The retractable shaft has separated from the bushing which is connected to the pull-wire being intended to release the stent.This most likely occurred during intervention when it was attempted to release the stent.Microscopic inspection revealed a rather small amount of remaining glue on the outside of the retractable shaft and no remaining glue inside the bushing.This finding indicates that the root cause for the complaint event is most likely related to the manufacturing process of a subassembly manufactured by a supplier.To prevent recurrence the respective internal departments were informed about this case and we are reviewing our quality systems processes.The supplier of the affected subassembly was informed about the complaint.

• Brand Name: PULSAR-18 T3 5/20/90
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10864553
• MDR Text Key: 217069607
• Report Number: 1028232-2020-05033
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130446458
• UDI-Public: 07640130446458
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: 430447
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03200627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1