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

Model Number	1009660J
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2025
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.
Event or Problem Description
It was reported the procedure was to treat in-stent thrombosis of a stent in the left anterior descending (lad) artery.During removal of the bmw universal guide wire, it caught on the previously implanted stent and the tip separated.The distal end was anchored to the diagonal, and the proximal end anchored with the stent from the previous procedure in the common trunk, with the proximal segment free floating in aorta.The patient remained hospitalized for observation.No additional information was provided.
Event or Problem Description
It was reported the procedure was to treat in-stent thrombosis of a stent in the left anterior descending (lad) artery.During removal of the bmw universal guide wire, it caught on the previously implanted stent and the tip separated.The distal end was anchored to the diagonal, and the proximal end anchored with the stent from the previous procedure in the common trunk, with the proximal segment free floating in aorta.The patient remained hospitalized for observation.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed on the returned device.The reported material separation was confirmed.The reported difficult to remove was not able to be replicated in a testing environment.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot of specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficulties and treatment appears to be related to circumstances of the procedure.Factors that may contribute to difficulty removing the guide wire include, but are not limited to challenging anatomy, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire.In this case, it was reported that the guide wire was caught on the previously implanted stent and the tip separated which likely led to the observed damages to the guide wire.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.B3 - date of event updated from (b)(6) 2026 to (b)(6) 2026.

• 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: 23643614
• Report Number: 2024168-2025-11748
• Device Sequence Number: 10132742
• Product Code: DQX
• UDI-Device Identifier: 08717648065866
• UDI-Public: (01)08717648065866(11)241107(17)261031(10)4110771
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1009660J
• Device Catalogue Number: 1009660J
• Device Lot Number: 4110771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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
• Patient Sex: Unknown