MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/120/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430483
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar 18 t3 self-expandable peripheral artery stent was positioned at the lesion site.After the stent had been deployed 2cm, the deployment wheel turned in a vacuum.The handle was examined, and it was observed that a metal wire was protruding from it.It was therefore necessary to dismantle the handle in order to finalize the deployment of the stent by creating a fixed withdrawal point.The stent was finally properly deployed, and no part of the deployment sheath was lost in the patient.
Additional Manufacturer Narrative
On 21-may-2024 additional information a 7 x 120 mm active stent was implanted and post-dilated at the common femoral level and at the superficial femoral level.The subsequent angiographic control was regarded very satisfactory.All materials were removed from the patients body.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 the reported event.In addition, the operative report provided was reviewed.In the as-returned state, the affected device was completely disassembled with several parts missing.The pull-wire has been torn or cut off about 383 mm distal to its proximal end.The distal portion of the pull-wire, the entire retractable shaft, the entire inner shaft with the device hub and the handle lever were not returned.In addition, the attachment of safety button on the inner surface of the handle has fractured.The state of the device does not allow any further analysis with regards to the root cause of the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause was identified.Due to the state of the returned device, the final root cause could not be determined.
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 the reported event.In addition, the operative report provided was reviewed.In the as-returned state, the affected device was completely disassembled with several parts missing.The pull-wire has been torn or cut off about 383 mm distal to its proximal end.The distal portion of the pull-wire, the entire retractable shaft, the entire inner shaft with the device hub and the handle lever were not returned.In addition, the attachment of safety button on the inner surface of the handle has fractured.The state of the device does not allow any further analysis with regards to the root cause of the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause was identified.Due to the state of the returned device, the final root cause could not be determined.

• Brand Name: PULSAR-18 T3 4/120/135
• 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: 18890486
• Report Number: 1028232-2024-01373
• Device Sequence Number: 19582538
• Product Code: NIP
• UDI-Device Identifier: 07640130446816
• UDI-Public: (01)07640130446816(17)2606
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 10/22/2024

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: 06/11/2026
• Device Model Number: 430483
• Device Catalogue Number: 430483
• Device Lot Number: 05232804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 10/22/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/21/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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