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

Model Number 430494

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Event 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needed.The complaint pulsar-18 t3 was advanced through the first placed stent, when resistance was felt.The stent was withdrawn out of the patient, and it was detected that the distal end of the catheter could be moved back and forth, separately from the shaft of the sds.

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
• Type of Device: 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
• MDR Text Key: 305608732
• Report Number: 1028232-2022-06476
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130446922
• UDI-Public: (01)07640130446922(17)2401
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1