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

Model Number	5640
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.No product was returned for inspection.Therefore, a returned product evaluation was not completed.The account was inquired on the procedure details.The response stated that the vessel had heavy calcium.Orbital atherectomy was performed.The procedure was able to be completed though it is unclear if the tip fragment is trapped in the calcium lesion.It is likely that the turnpike spiral was damaged during use.Based on information from the account and no returned product evaluation, the most likely root cause of the issue is undeterminable.
Event or Problem Description
It was reported that there was a peripheral pta atherectomy.It was noted that the distal tip of the turnpike spiral broke off in the mid posterior tib artery, which is heavily calcified.Snaring attempts to retrieve were unsuccessful.It is reported the patient (who is stable and doing well) will come back in attempt to remove later.No further complications were reported.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10195281
• Report Number: 2134812-2020-00038
• Device Sequence Number: 3408863
• Product Code: DQY
• UDI-Device Identifier: 30841156100708
• UDI-Public: (01)30841156100708
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

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 Model Number: 5640
• Device Lot Number: 653274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/25/2020
• 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: 88 YR