MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 5/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430489
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment.The catheter was torn (~ proximal 20cm) inside patient.Everything could be retrieved from the patient.Further information is requested.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment.The catheter was torn (~ proximal 20cm) inside patient.Everything could be retrieved from the patient.Further information is requested.
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 technical investigation confirmed that the inner shaft has fractured 490 mm proximal to its distal end.The inner shaft fragment shows severe constriction over a length of 460 mm, caused by the application of a high tensile force, most likely induced during the attempt to pull the device from the guide wire.In addition, compression marks were observed, which have most likely been induced during the removal of the guide wire from the distal fragment.The cause for the blockage between the inner shaft and the guide wire used in the intervention remains unresolved, as the guide wire was not returned.Review of the production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause was identified.

• Brand Name: PULSAR-18 T3 5/40/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 23801858
• Report Number: 8043892-2025-12048
• Device Sequence Number: 7707920
• Product Code: NIP
• UDI-Device Identifier: 07640130446878
• UDI-Public: (01)07640130446878(17)280722(10)07250097
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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 Model Number: 430489
• Device Lot Number: 07250097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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