MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WIGGLE GUIDE WIRES

Model Number	22299M-W30
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the mid left anterior descending (lad) coronary artery with moderate calcification, heavy tortuosity and 90% stenosis.The ht wiggle wire was used because a non-abbott scoring balloon catheter could not cross the lesion.The wiggle guide wire was advanced; however, caught on the balloon during advancement and was also stuck with the balloon catheter during removal.Therefore, the wiggle guide wire was removed as a single unit with the balloon catheter.A new scoring balloon catheter was advanced with a new wiggle guide wire and a supportive catheter to continue the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned 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.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: HI-TORQUE WIGGLE GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17209870
• Report Number: 2024168-2023-06830
• Device Sequence Number: 5540492
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

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: 07/31/2024
• Device Model Number: 22299M-W30
• Device Catalogue Number: 22299M-W30
• Device Lot Number: 2080861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NSE CUTTING BALLOON
• Patient Sex: Unknown