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

Model Number	5643
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event description stated that the distal tip of the catheter was broken.There was no returned product to evaluate.A manufacturing record review was completed and zero nonconformances were found.The most likely root cause for this event is damage during use.
Event or Problem Description
Distal tip broke.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER,
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6440007
• Report Number: 2134812-2017-00035
• Device Sequence Number: 10946721
• Product Code: DQY
• UDI-Device Identifier: M20656430
• UDI-Public: +M20656430/$$3180808597459G
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

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: 08/08/2018
• Device Model Number: 5643
• Device Lot Number: 597459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/28/2017
• Patient Sequence Number: 1