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

Model Number	5642
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Turnpike smooth was returned for evaluation.A manufacturing record review was completed and no related non-conformances were found therefore, supporting the device met material, assembly and performance specifications.The entire distal tip of the turnpike was separated.The separation point was twisted, and the coils were broken.This damage is consistent with over torquing the device.The turnpike ifu warns; "never advance, withdraw, or rotate an intravascular device against resistance until the cause of the 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.".
Event or Problem Description
The distal part of the tip of the catheter "broke off" while the cardiologist was in the middle of pci of the circumflex artery.The vessel size was 3.5mm of the circumflex artery and the artery was moderately tortuous.The patient was highly calcified and 99% occluded.Physician indicates he torqued both counter clockwise and clockwise about 10x consecutively each direction at a time.The physician was not able to retrieve the tip at that time, so physician chose to place a stent in the lesion, and the tip was pinned against the wall of the vessel by that stent.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9167890
• Report Number: 2134812-2019-00067
• Device Sequence Number: 2592516
• Product Code: DQY
• UDI-Device Identifier: 10841156100728
• UDI-Public: (01)10841156100728
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/17/2019

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: 07/25/2021
• Device Model Number: 5642
• Device Catalogue Number: 5642
• Device Lot Number: 653868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/08/2019
• 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
• Patient Age: 85 YR