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

Model Number	5640
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2020
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
It was reported that a unit was used during a cto pci study.During a cto pci procedure on the study subject it is reported that the tip of a turnpike spiral catheter broke off and had to be stented to the wall of the rca.No further complications were reported.Additional information received 24aug2020: during a cto pci procedure it is reported that the tip of a turnpike spiral catheter broke off and had to be stented to the wall of the rca.The lesion was in the proximal rca with a j-cto score of greater than 3.The lesion was 60 mm in length with the presence of calcium and a > 45o bend.1-2 mm of the tungsten tip of the turnpike spiral was visible in the rca under fluoroscopy.Resulted in stenting of the tip to the vessel wall.This procedure was also complicated by a perforation of the distal rca that was treated with prolonged balloon inflation and was deemed not related to the use of the study device.
Additional Manufacturer Narrative
One-unit model 5640 was returned to vsi for evaluation.The tip of the turnpike catheter showed signs of torquing in a calcified vessel.The very distal section was worn, and a small piece of the tip was missing.A manufacturing record review was completed and no related nonconformances were found.The damage is consistent with rotating the catheter in a calcified vessel.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: TRUNPIKE SPIRAL
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10466327
• Report Number: 2134812-2020-00053
• Device Sequence Number: 2390778
• Product Code: DQY
• UDI-Device Identifier: 20841156105089
• UDI-Public: (01)20841156105089
• Combination Product (Y/N): N
• 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): 08/07/2020

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: 5640
• Device Lot Number: 671042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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
• Patient Age: 77 YR
• Patient Weight: 84