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

Model Number	1000462HJ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
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 query of the complaint handling database for the reported lot revealed there is no indication of a level product quality issue.As the device was not returned for analysis, the investigation determined a conclusive cause for the reported difficulties cannot be determined.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
It was reported the bhw hydro guide wire (gw) was set aside to soak prior to use.When it was picked up again it was noted the guide wire was separated approximately 39cm from the distal tip.There was no patient involvement and no clinically significant delay in the procedure.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 query of the complaint handling database for the reported lot revealed there is no indication of a lot of level product quality issue.5 sterile/unused hi-torque balance heavyweight guidewire were returned.P/n: (b)(4), lot: 4102271.Visual and dimensional inspections on all five sterile units was performed with no observations or anomalies noted.Hypotube adhesion strength testing on all five (5) units was performed with no observations or anomalies noted.As there was no damage noted to the device during the inspection prior to use, it is possible that inadvertent mishandling resulted in compromising the device such that when setting the device aside in a tray with saline solution for approximately one hour resulted in further compromising the device and ultimately resulted in the reported material separation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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 obtained.It was reported the hi-torque bhw hydro guide wire was used in the coronary without issue.The guide wire was set aside in a tray with saline solution with the intention of using the guide wire again later in the procedure.When the physician picked up the guidewire from the tray, he realized that it was separated in two parts.There were no adverse patient effects and no clinically significant delay in the procedure.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: 22151277
• Report Number: 2024168-2025-05781
• Device Sequence Number: 15362193
• 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: SP
• 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): 12/18/2025

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?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown