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

Model Number 5639

Device Problem Separation Problem (4043)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record will be reviewed, a follow-up report will be issued after the investigation is complete.

Event Description

As reported: during use on a patient, the tip separated.

Manufacturer Narrative

No product was returned for evaluation.A manufacturing record review was completed and no related nonconformances were found.The event description states that the tip separated.A returned product evaluation was not completed.Additional information was requested.A response was received.The tip of the catheter fractured and stented against the wall.Procedure was completed on (b)(6) 2021.Patient died 5 days post procedure date.Physician stated that he did not believe this process would have any adverse effects on this patient.Turnpike had nothing to do with the death.It is unknown if the physician over torqued the tip during the case that lead to a tip separation.Without product evaluation, the type of damages that could have occurred at the tip and/or shaft cannot be determined.Based on the information, 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
• MDR Report Key: 11648085
• MDR Text Key: 244959398
• Report Number: 2134812-2021-00029
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20841156105041
• UDI-Public: (01)20841156105041
• Combination Product (y/n): N
• PMA/PMN Number: K191560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

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 Expiration Date: 11/19/2022
• Device Model Number: 5639
• Device Lot Number: 703984
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1