MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319J
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and dimensional inspections were performed to on the returned guide wire and the reported break was confirmed.The reported twisting was not confirmed; however, multiple bends were observed on the guide wire.The reported failure to advance and difficulty to remove from the implanted stent were unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance, difficulty to remove, guide wire break and bends appear to be related to operational circumstances of the procedure.In this case, it is likely that during re-advancement, the versaturn guide wire became tangled and twisted with the other devices used, causing the advancement issues and the difficulty to remove through the previously implanted stent.Manipulation against resistance ultimately resulted in the reported/noted core break and noted stretched coils.The noted bends on the guide wire likely occurred during and post procedure and due to handling.The noted teflon coating damage likely occurred during retraction through the torque device and or other accessory devices used in the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a left anterior descending artery (lad).Pre-dilatation was performed with a trek balloon and then pulled the versaturn guide wire (gw) into the ostium, stented, tried to put the versaturn back into distal lad where the extra s¿port wire was located.Resistance was noted with the previously deployed stent when advancing the versaturn gw and distal 30mm of the radiopaque portion of the wire looked like it was twisted around itself.There were also issues removing the guide wire due to the previously deployed stent.Ultimately the guide catheter was pulled back, along with the versaturn and removed altogether.Upon removal of the versaturn, it was noticed that the distal end of the wire was uncoiled.A prowater gw was used instead to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12041269
• Report Number: 2024168-2021-05250
• Device Sequence Number: 4215317
• Product Code: DQX
• UDI-Device Identifier: 08717648198496
• UDI-Public: 08717648198496
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: 01/31/2023
• Device Model Number: 1013319J
• Device Catalogue Number: 1013319J
• Device Lot Number: 1022071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTRA S¿PORT WIRE; TREK BALLOON
• Patient Weight: 101