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

Model Number 430502

Device Problem Activation Failure (3270)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

A pulsar-18 t3 self-expandable stent system was selected for treatment of a mildly calcified lesion in a mildly tortuous mid sfa.It was attempted to release the pulsar-18 t3 stent, but severe resistance was felt and the deployment wheel would not turn.The device was withdrawn, and another pulsar-18 t3 was deployed with no issues.The patient was treated successfully.

Manufacturer Narrative

The returned instrument was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation showed that the outer shaft has been retracted by about 7 mm.About 6 mm of the stent have been released.The rotating wheel at the handle is stuck and could not be further rotated.Opening of the handle revealed that the pull wire is not correctly routed inside the handle.Due to the wrong routing the safety button is only partially unlocked, forcing the pull wire to entangle with the rotating wheel which eventually caused a blockage.The most probable root cause for the complaint event is therefore related to the manufacturing process (assembly of the handle).

• Brand Name: PULSAR-18 T3 6/100/135
• 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: 17916431
• MDR Text Key: 325576717
• Report Number: 1028232-2023-05154
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130447004
• UDI-Public: (01)07640130447004(17)2602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 430502
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02232529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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