MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/40/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430459
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
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 affected device was returned inside a 4f merit medical prelude pro introducer sheath with about 2 mm of the device tip and a partially released stent protruding from the distal end of the introducer sheath.The retractable shaft of the affected device is severely deformed (i.E.Compressed) over a length of about 62 mm, starting at the proximal end of the introducer sheath.Outside of the deformed zone, the retractable shaft diameter complies with the specification.Scratch marks and indentations were observed at the distal end of the retractable shaft, at the device tip and at the distal end of the introducer sheath.The safety button at the handle is in the locked position.The partially released stent is slightly deformed at its distal end.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.During final inspection, every stent system undergoes visual inspection, and the outer shaft diameter is measured to 100 percent.Based on the conducted investigations, no material or manufacturing related root cause could be identified.The 4f merit medical prelude pro product label indicates an inner diameter of 1.3 mm.The inner diameter of the returned introducer sheath was found to be 1.47 mm.These values do not meet the specifications of pulsar-18 t3 (4f, >1.52 mm).The most probable root cause for the reported event is therefore related to a tolerance issue between the pulsar-18 t3 and the introducer sheath used in the intervention.
Event or Problem Description
While advancing a pulsar-18 t3 peripheral self-expandable stent system through a 4f sheath, it partially deployed itself within the sheath, leaving a small portion of the stent protruding out of the end inserted in the patients vessel.This caused the device to become stuck within the sheath.Both, sheath and deployment device were removed and exchanged.This did not cause any trauma to the patients vessel.

• Brand Name: PULSAR-18 T3 6/40/90
• 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: 20030249
• Report Number: 1028232-2024-04345
• Device Sequence Number: 18284203
• Product Code: NIP
• UDI-Device Identifier: 07640130446571
• UDI-Public: (01)07640130446571(17)2608
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 08/19/2024

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: 08/27/2026
• Device Model Number: 430459
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08230718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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