MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 7/100/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430512
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment.It was possible to implant the stent, but difficulties were noticed during implantation and withdrawal.Date of event unknown.
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 this event.The affected instrument was returned with a 4f terumo radifocus introducer sheath located about 550 mm proximal to the distal end of the stabilizer shaft.The introducer sheath is severely deformed, particularly at its distal end.Also, the stabilizer shaft is severely deformed, particularly about 550 mm proximal to its distal end.The distal end of the retractable shaft is located about 130 mm proximal to the proximal radiopaque marker, indicating that the retractable shaft has been retracted too far into the stabilizer shaft.Outside of the deformed zones the shaft diameters comply with the specification.Review of the product release documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The most probable root cause for the complaint event is related to the handling, i.E.Retracting the outer shaft too far.This caused a wrinkling/compression of both the stabilizer shaft and the introducer sheath and consequently led to the reported withdrawal difficulties.It should be noted that the ifu advises the user not to continue to turn the wheel after the stent has been fully deployed to avoid withdrawal difficulties.

• Brand Name: PULSAR-18 T3 7/100/135
• 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: 16019889
• Report Number: 1028232-2022-06527
• Device Sequence Number: 6951451
• Product Code: NIP
• UDI-Device Identifier: 07640130447103
• UDI-Public: (01)07640130447103(17)2509
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 12/16/2022

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: 09/04/2025
• Device Model Number: 430512
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07224602
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: Unknown