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

Model Number	5639
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned, however, investigation has not been completed.A follow-up report will follow after the evaluation is complete.
Event or Problem Description
Calcified lesion where only wire would pass.Dr.Tried regular turnpike then turnpike gold to get a catheter past the lesion to no avail.He then tried the turnpike lp.Again he pushed the catheter while torquing, the turnpike lp nosed into the lesion but did not pass through the lesion.After removal of the turnpike lp, it was noted a radiopaque piece on the wire.Dr.Tried snaring and buddy wire to remove this piece, but the lesion was so tight still nothing would navigate past.Dr.Removed wire slowly under fluro and piece came out of body with the wire.The extra piece now thought to be tip of turnpike lp is on the wire sent with device for inspection.Event was resolved when detached turnpike tip was removed on the wire as wire was removed.Lesion was then passed with roto wire and subsequent arthrectomy performed with good result to artery and good result for patient.
Additional Manufacturer Narrative
A manufacturing review was completed and zero nonconformances were found.The returned product evaluation determined that there was no material missing from the distal tip.The distal section had severe damage consistent with over-rotating the catheter in a calcified lesion.The most likely root cause for this is damage during use.The catheter was "frozen" on the guidewire and it could not be removed without cutting the catheter shaft.The distal tip was severely damaged.The tip section of the catheter was dissected by engineers to determine if all the tip material was present.The liner was intact and all the tip material was present.The catheter showed signs of damage consistent with the catheter being torqued while the distal section is not moving.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6878360
• Report Number: 2134812-2017-00072
• Device Sequence Number: 16307722
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/22/2017

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: 05/26/2019
• Device Model Number: 5639
• Device Lot Number: 608542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/16/2017
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 96