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

Model Number	5640
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformance's were found therefore, supporting the device met material, assembly and performance specifications prior to shipment.The product was not returned for evaluation.Based on the event details, it is likely that the turnpike spiral catheter was damaged while advancing or withdrawing through a calcified lesion.The coil most likely dislodged from the catheter shaft but remained intact and was removed attached to the turnpike spiral.We have initiated an internal non-conformance to address the late reporting of this event.
Event or Problem Description
Physician pulled on the turnpike spiral, when 2cm of the outer nylon coil was solidly entrapped in the calcification, the nylon was de-coiled from the catheter and attached to the microcatheter.No patient injury or medical intervention was reported.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8704352
• Report Number: 2134812-2019-00043
• Device Sequence Number: 11260638
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• 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): 11/14/2018

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: 04/04/2020
• Device Model Number: 5640
• Device Lot Number: 622954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1