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

Model Number	5638
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is related to the complaint received, but no patient impact was reported.A manufacturing record review was completed and zero nonconformance's were found therefore supporting that the device met material, assembly and performance specifications.A returned product evaluation was completed on the turnpike device and the evaluation confirmed the complaint received.The distal tip was found to be separated and a small piece was stuck in the coils of the guidewire.The distal tip section of the turnpike was severely twisted, consistent with over torquing the catheter against resistance.The ifu warns, "do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury".The probable root cause of the failure is damage during use as evidenced by the damage present to the device.
Event or Problem Description
Physician was using turnpike in a sub-total occlusion, trying to exchange the wiggle wire for a rotowire.He turned the catheter into the lad.There was calcium present, but not a full cto.The turnpike tightened down on the wiggle wire and part of the tip broke off and stayed on the wiggle wire.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7663780
• Report Number: 2134812-2018-00043
• Device Sequence Number: 16639090
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 06/06/2018

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: Physician
• Device Expiration Date: 04/13/2020
• Device Model Number: 5638
• Device Lot Number: 623693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 07/05/2018
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 111