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

Model Number	5642
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and no related non-conformances were identified, thus supporting that the device met material, assembly and performance specifications prior to shipment.A returned product evaluation was unable to be completed as no product was returned.Considering the complexity of the procedure and the calcium noted to be present within the vessel, the root cause could potentially be related to the operational context.However, this could not be confirmed as the device was not available for analysis.
Event or Problem Description
The device wasn't tested before use.This was a cto procedure of the rca, so was complicated, and there was calcium within the vessel.During use on patient, tip broke off, and had to be removed.The tip broke off on the wire, so the whole wire had to come out and be replaced by another one.No adverse injury to patient.The unit was discarded.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8019921
• Report Number: 2134812-2018-00078
• Device Sequence Number: 11045629
• Product Code: DQY
• UDI-Device Identifier: M20656420
• UDI-Public: M20656420
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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: 01/02/2020
• Device Model Number: 5642
• Device Lot Number: 618083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 MO
• Patient Weight: 114