MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/100/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430482
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment.The delivery system was positioned at lesion level, and the stent was ready to be released.The red button was pressed and the blue wheel rotated in order to release the stent, but it did not open, even though it was possible to see the braided shaft retracting thanks to the marker.Device was removed from the patient and another pulsar was successfully used in order to complete the procedure.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed that the retractable shaft has been retracted by about 206 mm.Scratches were observed at the distal end of the retractable shaft, both showing that the stent was present and eventually fully released.The stabilizer shaft is severely deformed at the transition to the handle lever, and the pull-wire has detached from the retractable shaft.These findings indicate that the rotating wheel was continuously turned after the stent had been fully deployed which is warned against in the ifu.Review of the production documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.During final inspection a 100 percent visual control of the stent area is performed.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.It remains unknown why the (release of the) stent could not be seen in the angiogram.

• Brand Name: PULSAR-18 T3 4/100/135
• 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: 16103954
• Report Number: 1028232-2023-00071
• Device Sequence Number: 18051412
• Product Code: NIP
• UDI-Device Identifier: 07640130446809
• UDI-Public: (01)07640130446809(17)2508
• 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): 04/27/2023

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: 08/13/2025
• Device Model Number: 430482
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07221004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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