MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TURNPIKE LP; CATHETER

Model Number 5638

Device Problem Material Perforation (2205)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be issued after the investigation is complete.

Event Description

As reported, the wire perforated the catheter.Patient condition unknown at time of report.Responses to multiple attempts for additional information to the customer has been unsuccessful.

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.There was no lot number provided for this complaint.Therefore, no record review could be complete.Case details were reviewed.The wire perforated the catheter.It is unknown what damages could have occurred on the shaft of the catheter.The location and the extent to which the perforation occurred is unknown.Ifu was reviewed and the following warning and precaution was noted: - never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.- exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.Additional information was requested from the account.No response was received.A manufacturing record review was not completed as no lot number was provided by the account.It is unknown if the wire perforation the catheter within the vessel.Procedure outcome is unknown.Based on the limited information and no product evaluation, the most likely root cause of the issue is undeterminable.

• Brand Name: TURNPIKE LP
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: marling heaton ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 14603655
• MDR Text Key: 293556566
• Report Number: 2134812-2022-00033
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K212211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1