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

Model Number	5642
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned for evaluation.
Event or Problem Description
The tip broke off inside patient during procedure, but it has been retrieved.No patient injury reported.
Additional Manufacturer Narrative
Attempts were made to capture device to return for evaluation.On 07 feb 2017 additional information was received that unfortunately the affected device has been disposed of, so there is nothing to return.

• Brand Name: TURNPIKE
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6245742
• Report Number: 2134812-2017-00003
• Device Sequence Number: 16224067
• Product Code: DQY
• UDI-Device Identifier: M20656420
• UDI-Public: +M20656420/$$3180706596459B
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

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: 07/06/2018
• Device Model Number: 5642
• Device Lot Number: 596459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 02/10/2017
• Patient Sequence Number: 1