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

Model Number 5640

Device Problem Material Fragmentation (1261)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 05/20/2020

Event Type  Injury  

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 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
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, mn ; 6564230
• MDR Report Key: 10195281
• MDR Text Key: 199503517
• Report Number: 2134812-2020-00038
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 30841156100708
• UDI-Public: (01)30841156100708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5640
• Device Lot Number: 653274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR