MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/120/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 430483

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

A pulsar 18 t3 self-expandable peripheral artery stent was positioned at the lesion site.After the stent had been deployed 2cm, the deployment wheel turned in a vacuum.The handle was examined, and it was observed that a metal wire was protruding from it.It was therefore necessary to dismantle the handle in order to finalize the deployment of the stent by creating a fixed withdrawal point.The stent was finally properly deployed, and no part of the deployment sheath was lost in the patient.

• Brand Name: PULSAR-18 T3 4/120/135
• 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: 18890486
• MDR Text Key: 337553210
• Report Number: 1028232-2024-01373
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130446816
• UDI-Public: (01)07640130446816(17)2606
• 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
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430483
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05232804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Date Device Manufactured: 06/13/2023
• 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