MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430494
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pulsar-18 t3 stent systems were chosen for treatment of the sfa.After predilatation and a successfully antegrade placement of a pulsar-18 t3 stent size 5/200/135, an extension was needed.The complaint pulsar-18 t3 was advanced through the first placed stent, when resistance was felt.The stent was withdrawn out of the patient, and it was detected that the distal end of the catheter could be moved back and forth, separately from the shaft of the sds.
Additional Manufacturer Narrative
This was reported on the wrong lot number.This report is being closed and the correct information is on mdr-1028232-2023-00527.

• Brand Name: PULSAR-18 T3 5/150/135
• 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: 15988015
• Report Number: 1028232-2022-06476
• Device Sequence Number: 12171409
• Product Code: NIP
• UDI-Device Identifier: 07640130446922
• UDI-Public: (01)07640130446922(17)2401
• 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): 12/14/2022

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: 01/13/2024
• Device Model Number: 430494
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12201886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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