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

Model Number	5638
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One-unit of turnpike lp was returned to vsi for evaluation.On inspecting the returned product, blood particulates were found along the length of the catheter.The turnpike was intact on the guidewire and could not be removed.Tip damage of the turnpike was confirmed.The tip sheared off and was caught on the guidewire.The distal end of the catheter had a small wrinkle.The shaft of the catheter had a wavy appearance which was noted at 20cm from the tip.This indicated torqueing of the catheter pushed against resistance.The damage from over torqueing caused the inner diameter (id) of the catheter to collapse and lock down on the wire.The measurements of the turnpike catheter were taken, the catheter met specifications and no other damage was noted.The manufacturing records associated with lot was reviewed, there were no non-conformances related to this lot therefore, supporting the device met material, assembly and performance specifications.Based on the information and return product evaluation, the most likely root cause was operational context and/or unintended use error.
Event or Problem Description
It was reported that the device failed to perform its function.No further complications were reported.Additional information was received 26feb2020: the event occurred during cx cto re-canalization (in-stent restenosis) without any actual feedback (no resistance) during torqueing and the micro-catheter (mc) got stuck inside turnpike lp.There was no possibility to move wire inside mc and finally both devices (wire with mc) had to be removed from the vessel.After visual inspection catheter was twisted around wire.The main point was no perceptible resistance when mc got stuck and started to twist.No further complications were reported.Manufacturer investigation was performed on 16mar2020 and it was noted that there was tip damage/separation.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9878533
• Report Number: 2134812-2020-00028
• Device Sequence Number: 16960852
• Product Code: DQY
• UDI-Device Identifier: 30841156100685
• UDI-Public: (01)30841156100685
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 10/07/2021
• Device Model Number: 5638
• Device Lot Number: 659503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 67