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

Catalog Number	1000462H
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a left anterior descending artery.The hi-torque balance heavyweight hydro guide wire crossed the lesion; however, the wire was noted to be fractured and the coils stretched.The device was removed successfully.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stretched coils were confirmed.The reported break was confirmed as a material separation.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.In this case, there was no damage or anomalies noted to the guide wire during the inspection prior to use or during preparation for use, which suggests a product quality issue did not contribute to the reported difficulties.Return device analysis noted the shaping ribbon separation occurred distal to the center solder.It is likely that the shaping ribbon separated during the procedure, possibly due to interaction with the anatomy; however, this cannot be confirmed.Additionally, it is likely that the coils became stretched during removal, due to the noted separation.Without the core/shaping ribbon intact, the coils can become deformed/stretched when met with resistance.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE HEAVYWEIGHT 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 # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17632576
• Report Number: 2024168-2023-09349
• Device Sequence Number: 6481345
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: 08717648015489
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K021228
• 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,Followup
• Report Date (Section B): 10/16/2023

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 Catalogue Number: 1000462H
• Device Lot Number: 2082372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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
• Patient Sex: Unknown