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	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 peripheral self-expandable stent system was selected for treatment.The device was advanced to the lesion, but the stent could not be released.The device and the wire were withdrawn and another stent was implanted.
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 the reported event.In addition, screens taken from the angiogram and the cathlab report provided were reviewed.The technical investigation revealed that the outer shaft has been fully retracted.The stent has been fully released and is entangled with the braided shaft and the inner shaft.Both the inner shaft and the stent are strongly kinked.At the distal end of the outer shaft, the braid and the marker ring are partially torn off.The marker ring is severely deformed.Outside of the deformed zones, the shaft dimensions comply with the specification.The safety button at the handle is in the unlocked position.Upon rotating the rotating wheel, the outer shaft retracted normally.Review of the angiographic material did not provide any further relevant information regarding the root cause of 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 of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• 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: 19944969
• Report Number: 1028232-2024-04200
• Device Sequence Number: 15479779
• Product Code: NIP
• UDI-Device Identifier: 07640130446779
• UDI-Public: (01)07640130446779(17)2607
• Combination Product (Y/N): N
• 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): 10/09/2024

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: 07/09/2026
• Device Model Number: 430479
• Device Catalogue Number: 430479
• Device Lot Number: 06235056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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