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

Model Number	5640
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Tip broke from the turnpike spiral, however, it stuck over the guidewire.They managed to get it out from the patient; with the guidewire together, the loose part was stuck on the guidewire.
Additional Manufacturer Narrative
The device returned to vsi on 28dec16, the investigation was conducted on (b)(6) 2017.Turnpike spiral was returned along with a 0.014" guidewire.The distal 2mm of the tip of the catheter was fixated onto the wire.The guidewire was bent at a 90° just proximal to the tip and the proximal end of the tip is locked onto the guidewire.The nylon threads were delaminated in one section however, still attached.It appears that the catheter was over torqued causing the distal tip to lock down (bind) on the guidewire and eventually separate.The turnpike ifu states "do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6247990
• Report Number: 2134812-2017-00004
• Device Sequence Number: 10977285
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: +M20656400/$$3180726597187A
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K142065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2016

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: Other
• Device Expiration Date: 07/26/2018
• Device Model Number: 5640
• Device Lot Number: 597187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• 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