MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 7/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430514
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment in the splenic artery.When the device was placed on the guidewire and advanced toward the patient, it abruptly stopped tracking and could not go any further.On closer inspection it was noted that there was a kink in the pulsar-18 t3 catheter where it meets the handle.It was deemed too risky to continue with that stent in case the kink damaged the wire or the vessel.So, it was removed and a new pulsar-18 t3 was used successfully.There was no adverse event for the patient.
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 the reported event.The technical investigation revealed several kinks in the device shaft about 43 mm, about 56 mm, about 392 mm and about 429 mm distal to the handle lever.A 0.018 inch reference guidewire could be fully introduced but increased friction was felt when passing the kinks.The guidewire used in the intervention was not returned.In addition, the braided shaft was found mildly deformed (i.E.Compressed) in its distal portion.At this location the diameter of the braided shaft does not comply anymore with the specification.Review of the production documentation confirmed that the device in question was manufactured according to specifications and passed all in-process and final inspections during which all devices are inspected for kinks and damages.In addition, a 100 percent control of the guide wire lumen viability 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.Please note that pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (pta), e.G.Residual stenosis and dissection.
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.The technical investigation revealed several kinks in the device shaft about 43 mm, about 56 mm, about 392 mm and about 429 mm distal to the handle lever.A 0.018 inch reference guidewire could be fully introduced but increased friction was felt when passing the kinks.The guidewire used in the intervention was not returned.In addition, the braided shaft was found mildly deformed (i.E.Compressed) in its distal portion.At this location the diameter of the braided shaft does not comply anymore with the specification.Review of the production documentation confirmed that the device in question was manufactured according to specifications and passed all in-process and final inspections during which all devices are inspected for kinks and damages.In addition, a 100 percent control of the guide wire lumen viability 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.Please note that pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (pta), e.G.Residual stenosis and dissection.

• Brand Name: PULSAR-18 T3 7/150/135
• 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: 18432844
• Report Number: 1028232-2024-00008
• Device Sequence Number: 7633190
• Product Code: NIP
• UDI-Device Identifier: 07640130447127
• UDI-Public: (01)07640130447127(17)2312
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,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: 12/21/2023
• Device Model Number: 430514
• Device Catalogue Number: 430514
• Device Lot Number: 12200627
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 02/14/2024; 12/09/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/15/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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