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

Model Number	5640
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for evaluation.Manufacturing records were reviewed no and nonconformances were related to this lot, therefore supporting the device met material, assembly and performance specifications.Torque damage was present on the turnpike shaft.It is likely that the turnpike spiral was rotated while the nylon coil section was engaged with a calcified lesion.
Event or Problem Description
Physician was doing a pci with our turnpike spiral 135cm catheter.The catheter tip unraveled and was pulled out, no harm to patient, they used a microcatheter to continue the case.

• Brand Name: TURNPIKE SPRIAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8856075
• Report Number: 2134812-2019-00053
• Device Sequence Number: 19461763
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: (01)10841156100704
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/05/2019

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: 05/10/2021
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 648785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 91