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	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event description stated that the distal tip of the turnpike lp catheter separated and was removed still attached to the wire.The event details described the vessel as a cto with heavy calcification and multiple attempts were made to cross the lesion.A returned product evaluation was completed and confirmed that the separated piece was still attached to the wire.The damage was consistent with advancing/withdrawing the catheter against resistance while rotating.A manufacturing record review was completed and zero nonconformances were found.The most likely root cause for this failure is damage during use.
Event or Problem Description
Cto of heavily calcified rca lesion.This was a very difficult lesion and multiple attempts were made to cross with the turnpike lp and spiral.During the procedure it was noticed that the tip of the turnpike lp had separated and was still attached to the wire.The wire and catheter was removed and taken off the field.The md stated that he was not surprised due to the manipulation.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6602177
• Report Number: 2134812-2017-00046
• Device Sequence Number: 700537
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: +M20656380/$$31903086051975
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2017

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: 03/08/2019
• Device Model Number: 5638
• Device Lot Number: 605197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/31/2017
• Patient Sequence Number: 1