MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/150/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 430464

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/05/2023

Event Type  malfunction  

Event Description

A pulsar-18 t3 self-expandable stent system was selected for treatment of a moderately to severely calcified lesion with 80 percent stenosis degree.During the procedure only a small section of the stent deployed.The physician had to snap off the handle to maneuver a pin-pull for the stent to fully deploy.

Manufacturer Narrative

The returned product 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 instrument was returned completely disassembled.Most of the returned components are severely deformed, most likely caused by application of high forces.The metal tube connector (bushing) has separated from both the outer shaft and the pull-wire.However, the bushing shows an imprint which appears as if it was induced by a tool such as e.G.Pliers.Unfortunately, the pull-wire and the winding wheel (which is attached to the pull-wire) were not returned for analysis.Moreover, the distal portion of the inner shaft has fractured and separated from the rest of the system.The distal portion of the inner shaft was also not returned.Review of the production 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, no material or manufacturing related root cause was identified.The final root cause for the reported event could not be determined.

• Brand Name: PULSAR-18 T3 6/150/90
• 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: 16206025
• MDR Text Key: 307700567
• Report Number: 1028232-2023-00265
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130446625
• UDI-Public: (01)07640130446625(17)2504
• 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: 01/06/2023

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: 430464
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03225838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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
• Patient Sex: Male