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

Model Number	5642
Medical Device Problem Codes	Detachment Of Device Component (1104); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation: one turnpike 135 cm was returned for evaluation.The catheter showed signs of biological contamination.The distal tip was severely damaged and about 2 mm were missing.The separated piece was not returned with the catheter.The guidewire was still inside the turnpike.The tip had "sanding" marks around it which is consistent with rotating in calcification.The tip is twisted which is consistent with over-rotating against resistance.The event description states that the device was torqued over 100 times.Ifu warns, "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.
Event or Problem Description
Difficult cto in the distal posterior lateral vessel.Very tortuous vessel with a stent on a turn.Turnpike was advanced on a wire, turnpike was torqued over 100 times and they believe that the turnpike tip got wedged/stuck on a stent strut which caused the tip to separate from the catheter.The tip was removed from the body on the wire.No patient impact reported.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6280544
• Report Number: 2134812-2017-00008
• Device Sequence Number: 153594
• Product Code: DQY
• UDI-Device Identifier: M20656420
• UDI-Public: +M20656420/$$31809095983429
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/09/2018
• Device Model Number: 5642
• Device Lot Number: 598342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2016
• Initial Report FDA Received Date: 01/26/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention