MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE LP; CATHETER

Model Number	5639
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: the turnpike lp was over the interventional guidewire and resistance was felt, it became stuck on the wire.The turnpike lp was reported as rotating a "half a dozen times" in each direction and kinked.The wire could not be pulled off as usual and required to be cut.The turnpike lp was removed with the wire, the wire tip broke and removed by a snare.
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The catheter was returned in multiple pieces.The pieces showed signs of torque damage consistent with the event details.The distal tip section of the catheter was severely damaged.It is unknown if the tip had any missing material based on the damage that was found.The most likely root cause for the failure is attributed to user error.The turnpike lp 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.".

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10677527
• Report Number: 2134812-2020-00070
• Device Sequence Number: 3105485
• Product Code: DQY
• UDI-Device Identifier: 20841156105058
• UDI-Public: (01)20841156105058
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: 5639
• Device Lot Number: 670912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention