MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/80/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430501
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a severely calcified lesion with 60 percent stenosis degree.After pre-dilatation, the device was advanced to the lesion but the stent could not be released.Another stent was used to finish the procedure.
Additional Manufacturer Narrative
The returned device 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process could be the cause for the reported event.The technical investigation revealed that the outer shaft has not been retracted but pushed over the tip.The safety button at the handle is in the unlocked position.Upon rotating the rotating wheel, the outer shaft did not retract.The stent has not been released and is entrapped between the tip and the outer shaft.The guide wire is stuck in the guide wire lumen and shows a delamination of its distal coating, causing the blockage.The outer shaft is severely widened in the area where it has been pushed over the device tip.The stopper shaft is severely compressed, and the stent is shortened, indicating that the complaint device was pushed against the blocked guide wire.The distal end of the outer shaft has elongated and necked close to the marker ring.This indicates that the release was attempted after the outer shaft has been pushed over the tip of the device.Outside of the deformed zones, the shaft dimensions comply with the specification.Review of the production documentation confirmed that the device was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The most probable root cause for the complaint event is the distal coating delamination of the guide wire used in the intervention.It should be noted that the pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries.

• Brand Name: PULSAR-18 T3 6/80/135
• 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: 20521473
• Report Number: 1028232-2024-05557
• Device Sequence Number: 15634504
• Product Code: NIP
• UDI-Device Identifier: 07640130446991
• UDI-Public: (01)07640130446991(17)2604
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 04/26/2026
• Device Model Number: 430501
• Device Catalogue Number: 430501
• Device Lot Number: 04230118
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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