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

Model Number	5641
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event description states that the end of the catheter started to unravel.A returned product evaluation found that the distal nylon coil of the turnpike was completely separated from the shaft.The catheter mid-shaft had damage consistent with rotating against resistance.A manufacturing review was completed and zero nonconformances were found.The most likely root cause is damage during use.
Event or Problem Description
The end of the catheter started to unravel.The spiral started to unravel but remained intact to the catheter and was removed.No intervention was required.Tortuosity and calcium were present.There was no adverse outcome.The catheter was removed without issue.Additional information received states, the catheter was removed and the distal nylon coil was still attached to the catheter shaft, no intervention was needed.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6902267
• Report Number: 2134812-2017-00075
• Device Sequence Number: 566567
• Product Code: DQY
• UDI-Device Identifier: M20656410
• UDI-Public: M20656410
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/01/2017

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: 04/07/2019
• Device Model Number: 5641
• Device Lot Number: 606531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/28/2017
• Patient Sequence Number: 1