MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL; WIRE, GUIDE, CATHETER

Model Number	1009660
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attachment medwatch report #mw5152302.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Medwatch uf/importer report# mw5152302 states: patient was having a cardiac catheterization.A drug-eluting stent was being placed in the obtuse marginal.Procedure was complicated by guidewire fracture resulting in a 15cm break in the wire.The computed tomography angiography post procedure confirmed an intra-aortic wire shaped foreign body originating in the left coronary artery extending into the ascending thoracic aorta and terminating in the mid to distal descending thoracic aorta.Individual had to be transferred to another facility with tcv services.Additional information was provided: it was reported the procedure was to treat a lesion in the obtuse marginal.A drug-eluting stent was placed.The bmw universal guide wire was advanced however met resistance at the coronary artery by pass graft.Resistance was met during retraction and the guide wire separated.Attempts to retrieve the separated portion were unsuccessful and the guide wire remained embedded in the mid to distal descending thoracic aorta.The patient was transferred to another facility for treatment.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties, treatment, and patient effect appear to be related to the operational context of the procedure.It was reported that the guide wire met resistance when attempting to cross a coronary artery bypass graft, resulting in the difficulty encountered during advancement and removal.Additionally, it was reported that the guide wire separated during removal.It is likely that manipulation of the device, when resistance was met, contributed to the material separation.The separated portion of the wire was embedded into a vessel.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19071389
• Report Number: 2024168-2024-04458
• Device Sequence Number: 11961654
• Product Code: DQX
• UDI-Device Identifier: 08717648014338
• UDI-Public: (01)08717648014338(17)250831(10)3091471
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K152709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 08/31/2025
• Device Model Number: 1009660
• Device Catalogue Number: 1009660
• Device Lot Number: 3091471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2023
• 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; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female