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

Model Number	5640
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit of turnpike spiral was returned for investigation and a manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The distal tip of the turnpike spiral was severely damaged, twisted, and fatigued.Due to the tip being chewed up badly, it is unlikely that there is anything missing from the catheter however, it is difficult to determine as tiny slivers of the tip material could have been detached.The damages noted on the tip is likely to have occurred during use in procedure.Per ifu states the following warning and precaution, · 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.· exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking additional information on the procedure was requested from the account.No response was received.The advancement issue of the turnpike spiral is likely due to the damages noted on the tip.Based on the information and returned product evaluation, the most likely root cause of the issue is operational context and/or unintended use error.
Event or Problem Description
As reported: physician found that the product failed to advance the lesion and closed the procedure using other's product.Sample was returned for investigation, and during investigation on (b)(6) 2021 it was found that the tip was severely damaged, and little slivers of the tip were missing.The tip was still attached.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11345479
• Report Number: 2134812-2021-00006
• Device Sequence Number: 17078034
• Product Code: DQY
• UDI-Device Identifier: 30841156100708
• UDI-Public: (01)30841156100708
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 01/19/2021

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: 12/09/2021
• Device Model Number: 5640
• Device Lot Number: 664139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1