MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/60/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430490
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment of a 60mm long lesion in a tibial vessel.The stent was unable to be deployed in the lesion.Safety mechanism was unlocked, and the wheel was turned, but the stent appears to be stuck on the delivery system.The system was removed from the patient with stent still in place.
Additional Manufacturer Narrative
20-nov-2023 incorrect lot number was originally reported.Correct lot number is 01222568.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 distal end of the retractable shaft is located about 7 mm proximal to the device tip.The stent has partially been released by 27 mm.The distal portion of the retractable shaft is severely deformed (i.E., kinked and compressed) at several locations, indicating application of a pushing force despite meeting resistance.Outside of the deformed zones, the diameter of the retractable shaft complies with the specification.Inspection of the remainder of the device revealed no other damage or irregularity.The safety button at the handle was still in the locked position (i.E., has never been pressed down).The rotating wheel has never been turned.The introducer sheath used in the intervention was returned and identified as a 4f cordis brite tip.The inner diameter of the returned introducer sheath was measured 1.42 mm.Due to the state of the device, it could not be inserted through the returned introducer sheath or through a reference introducer sheath.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, the retractable shaft of every stent system undergoes visual inspection, and a 100 percent control of the retractable shaft diameter 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.The initially reported event could not be reconstructed.The cause for the observed defects is most likely related to a tolerance issue with the introducer sheath used in the intervention.

• Brand Name: PULSAR-18 T3 5/60/135
• 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: 18152400
• Report Number: 1028232-2023-05858
• Device Sequence Number: 15451704
• Product Code: NIP
• UDI-Device Identifier: 07640130446885
• UDI-Public: (01)07640130446885(17)2502
• 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): 12/27/2023

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: 02/01/2025
• Device Model Number: 430490
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01222568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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