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

Model Number	5639
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing record will be reviewed, a follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: during use on a patient, the tip separated.
Additional 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
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11648085
• Report Number: 2134812-2021-00029
• Device Sequence Number: 19682296
• Product Code: DQY
• UDI-Device Identifier: 20841156105041
• UDI-Public: (01)20841156105041
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: 5639
• Device Lot Number: 703984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1