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

Model Number	5639
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to pass a 0.014" guidewire through shaft i.D.As it appears that there is dried biological matter inside the shaft.It appears the catheter shaft was over torqued.The strain relief was removed to visual the section of separation.The proximal catheter shaft was separated approximately 2mm from the hub.There was no noticeable damage to the remainder of the shaft.The root cause is associated to excessive torque applied during the procedure.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.Also, "never advance, withdraw or rotate an intravascular device against resistance until the cause of resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury." the submission of this mdr is part of a voluntary remedial action.
Event or Problem Description
Physician was doing a retrograde cto case.The proximal hub/torque boot broke off from main body of catheter.He was able to remove the turnpike lp catheter from the wire and used another turnpike lp during case.Physician reported he was meeting a lot of resistance while torqueing the turnpike lp but didn't pull back on catheter to relieve the torque build up or reverse the direction of torqueing.No patient impact reported.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8252511
• Report Number: 2134812-2019-00005
• Device Sequence Number: 11301241
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: Health Professional
• Device Expiration Date: 09/08/2018
• Device Model Number: 5639
• Device Lot Number: 598412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1