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

Model Number	5640
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
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: it was for a complex angioplasty procedure of the left coronary artery, highly calcified lesion of the circumflex artery.There was an attempt to clear the lesion by torque movement of a turnpike spiral on a guidewire.Quickly the end of the microcatheter broke and one end of the soft tungsten end remained hooked to the guide.The turnpike spiral, and guide set was removed and the procedure was stopped.There was no consequence for the patient.The broken tip of the turnpike spiral stayed on the guide, all has been removed from the patient, no consequences for the patient.
Additional Manufacturer Narrative
The device was returned for evaluation.A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The distal tip section of the turnpike spiral was severely damage.About 2mm of material was separated and was trapped in the coils of the returned guidewire.The separation point of the turnpike spiral was twisted and torn which is consistent with torquing the catheter against resistance.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.".

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10844984
• Report Number: 2134812-2020-00092
• Device Sequence Number: 11669952
• Product Code: DQY
• UDI-Device Identifier: 10841156105082
• UDI-Public: (01)10841156105082
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: 04/13/2022
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 671477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR