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

Model Number	1000462H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to implant a non-abbott pacemaker in an unknown coronary artery.A 190cm hi-torque bmw guidewire (gw) was advanced into the anatomy; however, a dissection was noted in the brachial artery, and the tip of gw was noted to be separated in the flap of the dissection.The separated tip was attempted to be retrieved using a snare device but was unable to be retrieved.The separated tip was then surgically removed.There was no reported adverse patient sequela; however, a clinically significant delay was noted.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
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 reported patient effect of dissection is listed in the hi-torque guide wires instruction for use as a known patient effect of coronary procedures.A conclusive cause for the reported difficulties and patient effect cannot be determined; however, the subsequent treatments appears to be related to the operational context of the procedure.It was reported that the distal portion of the guide wire separated during the procedure.Factors that may contribute to a material separation include, but are not limited to, tensile strength, corrosion, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported material separation.The separated portion of the guide wire was surgically removed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE HEAVYWEIGHT
• 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: 21091781
• Report Number: 2024168-2025-00243
• Device Sequence Number: 21066613
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: (01)08717648015489(17)260531(10)4061471
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: 05/31/2026
• Device Model Number: 1000462H
• Device Catalogue Number: 1000462H
• Device Lot Number: 4061471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown