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

Model Number	5640
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
When trying to advance a turnpike spiral through a very calcified lesion, the tip broke off, and got stuck in the lesion on the wire.The result was that nothing could pass over the wire.They could not advance anything over a parallel wire.This could of course was due to the lesion itself, but the broken tip did not make it easier.The wire itself was stuck because the rubber from the tip caused it to be jammed in the lesion.We managed to pull it out, put using considerable force.The case was successfully completed with a different microcatheter.
Additional Manufacturer Narrative
Turnpike spiral catheter was returned to vsi for evaluation.The catheter showed signs of biological contamination.The point of separation at the distal tip of the catheter along with the tungsten section stuck in the coils of the guidewire.The distal section of the catheter was severely damaged and fragments of the tungsten tip separated and were caught on the guidewire.The distal nylon coil was intact.The event description along with the returned product evaluation provided sufficient evidence to determine the most likely root cause.The distal section of the catheter was severely damaged and fragments of the tungsten tip separated and were caught on the guidewire.The distal tip was twisted and the ptfe inner layer was exposed.The most likely root cause was clinician misuse.The traveler was reviewed.There are no nonconformances related to this lot.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6229020
• Report Number: 2134812-2017-00001
• Device Sequence Number: 967468
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: +M20656400/$$31808225976726
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K142065
• 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,Followup
• Report Date (Section B): 12/09/2016

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: Physician
• Device Expiration Date: 08/22/2018
• Device Model Number: 5640
• Device Lot Number: 597672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/14/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other