MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 7/200/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430516
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment.The device could be advanced into the contralateral fsa.The red safety tab was pressed and the deployment wheel turned until it was supposed to end.Before removing the device, the doctor noticed that the stent had been released to 170-180 mm.The deployment wheel was then pressed several times.With force the wheel could then be released and turned again, and the stent was released normally.
Additional Manufacturer Narrative
Neither the affected device nor the angiographic material was returned.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 device 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 determined.

• Brand Name: PULSAR-18 T3 7/200/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 18330999
• Report Number: 1028232-2023-06350
• Device Sequence Number: 17820673
• Product Code: NIP
• UDI-Device Identifier: 07640130447141
• UDI-Public: (01)07640130447141(17)2601
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 01/22/2026
• Device Model Number: 430516
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01231368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown