MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC BANDIT GUIDEWIRE; CATHETER GUIDEWIRE

Model Number	7444
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One-unit of bandit guidewire model 7444 was returned to vsi for evaluation.Which is the only complaint wire associated to this event from vsi.A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.Blood particulates were seen along the length of the catheter.Damage was noted.Most of the polymer coating was scraped off.Coil was stretched distally.The polymer delamination and coil stretching indicates guidewire movement against resistance.No other damage was seen along the length of the catheter.Investigation is in progress; when results or further information is received a follow-up report will be submitted.
Event or Problem Description
It was reported that a cto of the rca with tortuosity and heavy calcium burden was performed.The bandit guidewire navigated the microchannel well, however, the turnpike spiral was unable to get through the tight calcified bend and continuously buckled and they were unable to advance a balloon over the bandit wire as it was getting stuck on the wire.Upon removal of the wire it was seen that the polymer had bunched up.They then took a different (second) wire and were unable to advance this wire through the tight lesion.For their final attempt they used another wire for a "hole-in-one" technique where they spin the wire as fast as they can and hope that it will go through the microchannel.They had issues advancing this wire through the same tight calcified bend and the turnpike spiral was still unable to move beyond this bend.During the spinning of this wire, it snapped.Due to the cto of the rca and the heavy calcium.Site decided to leave this piece of wire in the vessel and aborted the case.No further complications were reported.
Additional Manufacturer Narrative
Supplier was notified of this complaint and an analysis pertaining to the manufacturing record review was requested.An inspection of the peeling of the polymer jacket part was implemented.The test record for polymer jacket peeling off was reviewed and confirmed specifications were met.Based on the manufacturing records, the same failure did not occur during production.The instructions for use (ifu) stated the following, "never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel injury" and "exercise care in handling the guidewire during a procedure to reduce the possibility of accidental breakage or kinking".Based on the information and return product evaluation, the most likely root cause was operational context and /or unintended use error.

• Brand Name: BANDIT GUIDEWIRE
• Common Device Name: CATHETER GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9819764
• Report Number: 2134812-2020-00022
• Device Sequence Number: 11545662
• Product Code: DQX
• UDI-Device Identifier: M20674440
• UDI-Public: M20674440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181647
• 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,Followup
• Report Date (Section B): 02/11/2020

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: 08/19/2021
• Device Model Number: 7444
• Device Lot Number: 655840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR