MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/120/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430463
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 stent system was chosen for the treatment.The stent could not be released and after removal a kink was detected.
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process could be the cause for the reported event.The technical investigation revealed that the outer shaft has not been retracted and that the stent has not been released.The retractable shaft has separated from the bushing which is connected to the pull wire being intended to release the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.However, a strong kink was observed in the device shaft which may have contributed to the complaint event.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 sub assembly was informed about the complaint.

• Brand Name: PULSAR-18 T3 6/120/90
• 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: 10758855
• Report Number: 1028232-2020-04702
• Device Sequence Number: 19117372
• Product Code: NIP
• UDI-Device Identifier: 07640130446618
• UDI-Public: 07640130446618
• 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): 10/29/2020

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: 04/09/2023
• Device Model Number: 430463
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03206006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1