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

Model Number	1001780-HC
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
User facility medwatch report received that states: wire fraying resulting in broken tip.Hypertension, coronary artery disease, socratic arthritis, pacemaker, and questionable artial fibrillation.Additional information was provided that the procedure performed was to treat a left circumflex coronary artery (cx).During advancement of the 3cm hi-torque (ht) 014 balance middleweight (bmw) guide wire, difficulty was noted due to the anatomy, from the left anterior descending coronary artery to the cx.After removal, it was observed that the tip of the ht bmw guide wire separated.The separated portion was crushed against the vessel wall with a drug-eluting stent.An unspecified whisper guide wire was used with an unspecified stent to complete the procedure.Additional information reported that the patient died; however, in the physician's opinion, the bmw guide wire did not cause or contribute to the patient's death.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Attachment: medwatch report.
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed to the returned device.The reported material separation was confirmed.The reported difficult to advance was not confirmed as the exact conditions of the device during the procedure could not be replicated in a testing environment and the condition of the returned device with the tip and coils separation.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 specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficulty and subsequent treatment appear to be related to circumstances of the procedure.Factors that may contribute to difficulty advancing 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 is likely that the challenging anatomy contributed to the reported difficulty and likely led to the reported material separation and observed damages to the guide wire, as it was reported that the physician noted difficulties related to the anatomy.Reportedly, the patient passed away, however, in the physician¿s opinion, the guide wire did not cause or contribute to the patient¿s death.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.B2 correction: required intervention added.
Event or Problem Description
User facility medwatch report received that states: wire fraying resulting in broken tip.Hypertension, coroanry artery disease, scoriatic arthritis, pacemaker, and questionable artial fibrillation.Additional information was provided that the procedure performed was to treat a left circumflex coronary artery (cx).During advancement of the 3cm hi-torque (ht) 014 balance middleweight (bmw) guide wire, difficulty was noted due to the anatomy, from the left anterior descending coronary artery to the cx.After removal, it was observed that the tip of the ht bmw guide wire separated.The separated portion was crushed against the vessel wall with a drug-eluting stent.An unspecified whisper guide wire was used with an unspecified stent to complete the procedure.Additional information reported that the patient died; however, in the physician's opinion, the bmw guide wire did not cause or contribute to the patient's death.No additional information was provided.

• 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23429651
• Report Number: 2024168-2025-11288
• Device Sequence Number: 9863205
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: (01)08717648025969(11)250127(17)261231(10)5012772
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 5012772
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White