MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/40/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430439
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment for a severely calcified popliteal lesion.The deployment and implantation of the stent was successfully performed.When it was tried to retrieve the shaft, only the external part of the triaxial system came out leaving behind the 2 components of the system on the guidewire.It was managed to retrieve both components one after the other out of the patient.No parts were left inside the patient.
Additional Manufacturer Narrative
Combination product: yes.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 separated into three parts (i.E.The inner shaft, the stopper shaft and the remainder of the system consisting of the handle, the handle lever, the retractable shaft and the stabilizer shaft).Both the inner shaft and the stopper shaft have detached from the luer body at the handle.The two shafts are not deformed or damaged.The shaft dimensions still comply with the specification.Surface and material analysis revealed the absence of uv glue which is used to fixate the two shafts inside the luer body.Additional communication with the hospital confirmed that the deployment and implantation went very well, the patient is fine.To prevent recurrence the respective internal departments were informed.
Additional Manufacturer Narrative
Combination product: yes, 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.The affected device was returned separated into three parts (i.E.The inner shaft, the stopper shaft and the remainder of the system consisting of the handle, the handle lever, the retractable shaft and the stabilizer shaft).Both the inner shaft and the stopper shaft have detached from the luer body at the handle.The two shafts are not deformed or damaged.The shaft dimensions still comply with the specification.Surface and material analysis revealed the absence of uv glue which is used to fixate the two shafts inside the luer body.Additional communication with the hospital confirmed that the deployment and implantation went very well, the patient is fine.To prevent recurrence the respective internal departments were informed.
Additional Manufacturer Narrative
Combination product: yes.Corrected the initial reporter information.Reference capa# nc-24-004.The technical investigation revealed that the inner shaft and the stopper shaft have detached from the luer body inside the handle due to absence of uv glue which is used to fixate the two shafts inside the luer body.The respective internal departments were informed and to prevent recurrence, it was decided that the 4-eyes principle was introduced for the in-process control of the luer bonding.The corrective action has been successfully closed.
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment for a severely calcified popliteal lesion.The deployment and implantation of the stent was successfully performed.When it was tried to retrieve the shaft, only the external part of the triaxial system came out leaving behind the 2 components of the system on the guidewire.It was managed to retrieve both components one after the other out of the patient.No parts were left inside the patient.

• Brand Name: PULSAR-18 T3 4/40/90
• 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: 19264593
• Report Number: 1028232-2024-02541
• Device Sequence Number: 11434278
• Product Code: NIP
• UDI-Device Identifier: 07640130446373
• UDI-Public: (01)07640130446373(17)2610
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/12/2025

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: 430439
• Device Catalogue Number: 430439
• Device Lot Number: 10232586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 11/05/2024; 05/12/2025
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/16/2024; 11/06/2024; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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