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

Model Number	1000462HJ
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2025
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 a heavily calcified lesion in the right circumflex (rcx) artery.A non-abbott microcatheter did not pass the lesion therefore the bhw guide wire was advanced and able to cross the distal rcx.The microcathter was attempted to be advanced over the bhw with turning movements of the microcathter.During this try the radiopaque tip of the guide wire broke into two parts.The proximal end of the guide wire was able to be retracted; however the tip of the guide wire was in the distal part of the rcx and was not removed.The patient required an extended hospital stay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported tip material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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 similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the high-grade, heavily calcified anatomy resulting in the reported difficult to advance.Interaction with the heavily calcified anatomy in conjunction with manipulation of devices as the microcatheter was advanced over the guide wire using turning movements resulted in the noted misaligned coils and ultimately resulted in the reported/noted material separation.As reported, no attempt was made to retrieve the separated distal tip of the guidewire due to the very distal location and distally tortuous vessel.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.
Event or Problem Description
Subsequent to the initially filed reports, additional information was provided.Resistance was met during advancement due to the high-grade, calcified lesion.No attempt was made to retrieve the separated distal tip of the guidewire due to the very distal location and distally tortuous vessel.No additional information was provided.

• 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: 23198549
• Report Number: 2024168-2025-10665
• Device Sequence Number: 9729651
• Product Code: DQX
• UDI-Device Identifier: 08717648015496
• UDI-Public: (01)08717648015496(11)241022(17)260930(10)4102271
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/03/2025

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 Expiration Date: 09/30/2026
• Device Model Number: 1000462HJ
• Device Catalogue Number: 1000462HJ
• Device Lot Number: 4102271
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: Other; Hospitalization
• Patient Sex: Unknown