MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/100/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430502
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 self-expandable stent system was selected for treatment of a moderately calcified lesion in the mid part of the moderately tortuous right sfa.After advancing the device to the disease site and pressing the red release button, the wheel became harder and harder to turn during deployment.After struggling to turn the wheel, the stent finally deployed but was then stuck on the wire.The system/wire was pulled out and a new wire was used to recross stent and balloon.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In the as-returned state the csi 0.014 inch viperwire was stuck in the guidewire lumen of complaint instrument.The stent has been fully released.The outer shaft has been retracted by about 100 mm but got stuck in the blue stabilizer shaft.Microscopic inspection of the outer shaft revealed numerous small kinks over a length of about 130 mm.Similar small kinks were observed at the stabilizer shaft.The stabilizer shaft is also severely compressed at the transition to the handle lever and distal to the handle lever.The shaft length from distal end of the handle lever to distal end of the device tip does not comply anymore with the specification.The rotating wheel is stuck and cannot be further turned.Opening of the handle showed that also the inner shaft with the viperwire inside is severely deformed (i.E.Forms a loop and is strongly kinked) just distal to the device hub.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process controls as well as the final inspection during which a 100 percent control of the wire lumen viability is performed.Based on the conducted investigations, no manufacturing or material related root cause was determined.It seems likely that the utilization of a viperwire has contributed to the complaint event.The exact sequence of events cannot be reconstructed.According to the manufacturer csi360, viperwire advance peripheral guide wires are designed specifically for the diamondback 360 orbital atherectomy systems.Please note that, according to the pulsar-18 t3 ifu, the user is advised to exercise care during handling to reduce the possibility of kinking of the delivery system shaft.

• Brand Name: PULSAR-18 T3 6/100/135
• 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: 17004054
• Report Number: 1028232-2023-02678
• Device Sequence Number: 7168716
• Product Code: NIP
• UDI-Device Identifier: 07640130447004
• UDI-Public: (01)07640130447004(17)2511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 11/16/2025
• Device Model Number: 430502
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11220075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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: Female