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

Model Number	1009664J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2025
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.B3 - for reporting purposes, the date of event/procedure will be estimated as (b)(6) 2025.
Event or Problem Description
It was reported the bmw universal ii guide wire was used in the patient however separated.The separated portion was unable to be removed and remains in the patient.Per the physician the patient is doing well.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that inadvertent mishandling during use resulted in the reported tip material separation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.As reported, the separated portion was unable to be removed and remains in the patient.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT¿
• 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: 22700696
• Report Number: 2024168-2025-07965
• Device Sequence Number: 9150340
• Product Code: DQX
• UDI-Device Identifier: 08717648118753
• UDI-Public: (01)08717648118753(11)250317(17)270228(10)5031771
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 08/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1009664J
• Device Catalogue Number: 1009664J
• Device Lot Number: 5031771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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: Other
• Patient Sex: Unknown