MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/170/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 430505

Device Problem Positioning Failure (1158)

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

Event Date 10/05/2020

Event Type  malfunction  

Event Description

A pulsar-18 t3 peripheral stent system was chosen for treatment.The stent was placed, the red release button was pressed, the wheel was turned but nothing happened.Apparently, there was no connection from the wheel to the shaft.The stent was removed and a new stent was released without any problems.

Manufacturer Narrative

The complaint instrument was not returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation for the product detailed above confirmed that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no material or manufacturing related root cause could be identified.The final root cause for the reported event could not be determined.

• Brand Name: PULSAR-18 T3 6/170/135
• 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: 10972214
• MDR Text Key: 220417351
• Report Number: 1028232-2020-05402
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130447035
• UDI-Public: 07640130447035
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: 430505
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03205747
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1