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

Catalog Number	1001780J-HC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion.The hi-torque balance middleweight hydro 014 guidewire was attempted to be advanced; however, it was noted separated; therefore, the device was retrieved.Another unspecified device was used to complete the procedure.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.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/complaints from this lot.The investigation determined the reported material separation and subsequent treatment appear to be related to the operational context of the procedure.In this case, return device analysis noted the fracture faces of the guide wire were jagged and a bend was noted at the separation.This indicated that the guide wire likely separated due to force at a kink or bend.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.It is likely that interaction with the patient¿s anatomy or an accessory device resulting in the material separation and coil damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT 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: 17491210
• Report Number: 2024168-2023-08569
• Device Sequence Number: 7252772
• Product Code: DQX
• UDI-Device Identifier: 08717648025983
• UDI-Public: 08717648025983
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 1001780J-HC
• Device Lot Number: 2012171
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown