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	05/29/2025
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 bhw hydro guide wire (gw) was placed in a saphenous vein.The procedure continued to address other lesions; however upon completion, when attempting to remove the bhw, it was noticed that part of the gw was outside the catheter while another part protruded through the catheter into the saphenous vein.The guidewire had separated into two pieces.Since the distal part remained inside the catheter for about 5 cm, it was captured with a balloon and the entire assembly (catheter, part of the guidewire, and balloon) was removed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported the bhw hydro guide wire (gw) was placed in a saphenous vein.The procedure continued to address other lesions; however upon completion, when attempting to remove the bhw, it was noticed that part of the gw was outside the catheter while another part protruded through the catheter into the saphenous vein.The guidewire had separated into two pieces.Since the distal part remained inside the catheter for about 5 cm, it was captured with a balloon and the entire assembly (catheter, part of the guidewire, and balloon) was removed.There were no adverse patient effects 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.The investigation determined a conclusive cause for the reported material separation cannot be determined.It is possible that soaking the guide wire in a basin with saline solution for later use contributed to the reported material separation; however this cannot be confirmed.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 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: 22227095
• Report Number: 2024168-2025-06207
• Device Sequence Number: 8505844
• 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?: 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?: 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: 12/16/2025
• Initial Report FDA Received Date: 06/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown