MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/80/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430461
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 self-expandable stent system was selected for treatment but could not be introduced into the introducer 4fr cook, because it was blocked.The introducer was changed to 5f and the stent could be introduced into the patients artery.
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.In the as-returned state the distal portion of the affected device was located inside a 4f merit medical prelude pro introducer sheath with about 21 mm of the device inner shaft (incl.Device tip) protruding from the distal end of the introducer sheath.After removal of the device, it became apparent that the outer shaft has been fully retracted and severely deformed at several locations.Particularly in its distal portion, the outer shaft shows severe compression marks, surface abrasions and a severely damaged tip ring.Outside of the damaged zones, the retractable shaft diameter complies with the specification.In the as-returned state, the safety button at the handle was pressed down (i.E.In the unlocked position).The rotating wheel has been rotated several times.The stent has been released and was not returned.The returned introducer sheath is undamaged and has a minimum inner diameter of 1.45 mm.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 of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The product label of 4f merit medical prelude pro indicates an inner diameter of 1.3 mm, and the inner diameter of the returned introducer sheath was found to be 1.45 mm which does not meet the specifications of pulsar-18 t3 (4f, >1.52 mm).The root cause for the complaint event is therefore most likely related to a tolerance issue between the two devices.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.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.In the as-returned state the distal portion of the affected device was located inside a 4f merit medical prelude pro introducer sheath with about 21 mm of the device inner shaft (incl.Device tip) protruding from the distal end of the introducer sheath.After removal of the device, it became apparent that the outer shaft has been fully retracted and severely deformed at several locations.Particularly in its distal portion, the outer shaft shows severe compression marks, surface abrasions and a severely damaged tip ring.Outside of the damaged zones, the retractable shaft diameter complies with the specification.In the as-returned state, the safety button at the handle was pressed down (i.E.In the unlocked position).The rotating wheel has been rotated several times.The stent has been released and was not returned.The returned introducer sheath is undamaged and has a minimum inner diameter of 1.45 mm.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 of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The product label of 4f merit medical prelude pro indicates an inner diameter of 1.3 mm, and the inner diameter of the returned introducer sheath was found to be 1.45 mm which does not meet the specifications of pulsar-18 t3 (4f, >1.52 mm).The root cause for the complaint event is therefore most likely related to a tolerance issue between the two devices.

• Brand Name: PULSAR-18 T3 6/80/90
• 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: 18535666
• Report Number: 1028232-2024-00343
• Device Sequence Number: 20757646
• Product Code: NIP
• UDI-Device Identifier: 07640130446595
• UDI-Public: (01)07640130446595(17)2607
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 430461
• Device Catalogue Number: 430461
• Device Lot Number: 06234909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 12/11/2024
• 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