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

Model Number	1009661
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the production record for the reported lot was performed and revealed no manufacturing nonconformities.A review of the corrective and preventative actions (capa) database for the device was performed and revealed no complaint assessment capas.A query of the complaint handling system for the reported lot was performed and revealed no other complaints reported for this lot.Based on the complaint review, there is no indication of a lot specific product quality issue.Based on the information provided, a definitive cause for the reported issue could not be determined.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 tip separation.The separated portion of the tip remains within the anatomy.Based on the 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.
Event or Problem Description
Mdr report#: mw5177744.During a right heart catheterization, the distal part of the bmw 300cm wire broke off inside the distal rpa.Wire fragment was retained in the distal right lower lobar lateral segmental branch.Additional information was received.Attempts were made to retrieve the separated portion of the guide wire, however were unsuccessful.The separated portion remains in the distal right lower lobar lateral segmental branch.

• 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: 23643642
• Report Number: 2024168-2025-11749
• Device Sequence Number: 18682151
• Product Code: DQX
• UDI-Device Identifier: 08717648014345
• UDI-Public: (01)08717648014345(11)250613(17)270531(10)5061371
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 1009661
• Device Catalogue Number: 1009661
• Device Lot Number: 5061371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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: Required Intervention
• Patient Age: 24 DA
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Race: Asian