MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430479
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment.Upon opening the box, it was noticed that the stent was damaged.Therefore, it was not inserted into the patient, and another pulsar-18 t3 was used successfully for the procedure.
Additional Manufacturer Narrative
The affected device was not returned and could therefore not be subjected to a technical investigation.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 confirmed that the device was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.Based on the conducted investigations, no material or manufacturing related root cause could be identified.

• Brand Name: PULSAR-18 T3 4/40/135
• 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: 18243203
• Report Number: 1028232-2023-06060
• Device Sequence Number: 6571844
• Product Code: NIP
• UDI-Device Identifier: 07640130446779
• UDI-Public: (01)07640130446779(17)2505
• 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: 05/28/2025
• Device Model Number: 430479
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04220960
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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