MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/80/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430451
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Pulsar-18 t3 stent system was chosen for treatment of a moderately calcified lesion (80 percent stenosis degree) in the sfa.After positioning in the target lesion it was not possible to release the stent and the device was therefore removed.
Additional 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 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 the 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 glue on the inside of 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.The stent is still partly crimped under the retractable shaft and is partially released, which was reported intentionally by the physician after withdrawal of the complaint instrument.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 5/80/90
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10284214
• Report Number: 1028232-2020-02941
• Device Sequence Number: 14166571
• Product Code: NIP
• UDI-Device Identifier: 07640130446496
• UDI-Public: 07640130446496
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 430451
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10194027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1