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

Model Number	5642
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found, therefore supporting the device met material, assembly and performance specifications prior to shipment.One turnpike smooth catheter and a guidewire were returned for evaluation.The distal section of the catheter was twisted, which is consistent with rotating the catheter against resistance.1mm of the turnpike tip was separated from the catheter and remained on the guidewire.The tip material was caught in the damaged guidewire coils.
Event or Problem Description
Tip of turnpike broke off.Additional information received 26apr19: the tip broke; however, was still attached.The tip was retrieved, and case completed.The vessel was eventually ballooned, and another turnpike was used to deliver a des.No patient injury or impact reported.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8633285
• Report Number: 2134812-2019-00036
• Device Sequence Number: 2017380
• Product Code: DQY
• UDI-Device Identifier: 10841156100728
• UDI-Public: (01)10841156100728
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2021
• Device Model Number: 5642
• Device Catalogue Number: 5642
• Device Lot Number: 642125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 85