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

Model Number	5640
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after invesigation.
Event or Problem Description
It was reported that: "tip broke" additional information has been requested from the account.
Additional Manufacturer Narrative
Qn# (b)(4).One-unit of the turnpike spiral was returned for evaluation.Blood particulates were noted on the unit.The tip was observed to be fatigued, torqued, and damaged.Tip was observed to be around 10-11 mm.No significant tip separation was observed.A device history record review was completed.All processes were followed.No issues noted.Case details were reviewed.Customer stated tip broke.The damages are likely to have occurred during use in the procedure when operated against resistance.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.Do not rotate the catheter more than two (2) consecutive 360 rotations in either direction if the distal tip is not also rotating and advancing, as it may result in separation of the catheter, damage to the catheter, or vessel injury.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.Additional information was requested.No response was received.The damages noted on the tip indicate that the catheter was torqued and rotated against resistance leading the tip material being fatigued and unraveled.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.
Event or Problem Description
It was reported that: "tip broke".Additional information has been requested from the account.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: angela meister ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16184599
• Report Number: 2134812-2023-00001
• Device Sequence Number: 14111838
• Product Code: DQY
• UDI-Device Identifier: 10841156108755
• UDI-Public: 10841156108755
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 03/08/2024
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 73C2200297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown