MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING

Model Number	22299M-W30
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a re-stenosed lesion in a heavily tortuous unspecified vessel.The wiggle guide wire was unable to cross and resistance was noted during removal from the anatomy.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents there is no indication of a lot specific product quality issue.The investigation determined the reported failure to advance and difficulty to remove appear to be related to operational circumstances of the procedure.Based on the reported information, the reported heavily tortuous, mildly calcified and 75% stenosed anatomy was the likely cause of the reported failure to advance and difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, the lesion was located in the left circumflex artery that was heavily tortuous, mildly calcified and 75% stenosed.The procedure was completed without the use of another device.No additional information was provided.

• Brand Name: HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12356982
• Report Number: 2024168-2021-07421
• Device Sequence Number: 3726366
• Product Code: DQX
• UDI-Device Identifier: 08717648079726
• UDI-Public: 08717648079726
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 08/31/2021
• Device Model Number: 22299M-W30
• Device Catalogue Number: 22299M-W30
• Device Lot Number: 9091061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1