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

Model Number	1001780-HC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a lesion in the left anterior descending artery.After completion of the procedure it was noted the bmw hydro guide wire had separated inside the patient.The separated portion was removed with other devices.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 specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.The subsequent treatment appears to be related to circumstances of the procedure.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 results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.
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 specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.The subsequent treatment appears to be related to circumstances of the procedure.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 results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.B3: date of event updated from (b)(6) 2025 to (b)(6) 2025.
Event or Problem Description
Subsequent to the initially filed reports, additional information was received.It was reported the procedure was to treat a lesion in the left anterior descending artery.Upon successful puncture, a 6f sheath was inserted.A hydrophilic guidewire (gw) was introduced through the sheath and successfully passed through the anastomosis, navigated through the radial artery stenosis, and reached the brachial artery.A kmp catheter was then advanced over the hydrophilic gw to exchange for a bmw hydro gw.The process was smooth, and the kmp catheter was withdrawn.A balloon catheter (3 mm in diameter, 15 mm in length) was planned to be advanced to the lesion site.Resistance was encountered when the balloon reached the anastomosis.After confirming the position, a slight force was applied to advance the balloon, but it failed to cross the anastomosis and reach the lesion.A stiffer gw was planned for replacement.Upon withdrawing the bmw hydro gw, it was found to be separated.Ultrasound revealed a gw shadow from the radial artery to the brachial artery, suggesting that the bmw hydro gw had fractured, with a fragment retained in the patient¿s radial artery.The medical team observed that the patient's vital signs remained stable.However, considering the retained gw fragment in the radial artery could damage surrounding tissues and potentially lead to a serious medical incident, urgent intervention was deemed necessary.Emergency surgery was arranged where a left forearm autogenous arteriovenous fistula reconstruction was performed, along with removal of the retained gw fragment.There were no adverse patient effects and no clinically significant delay in the procedure.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 # 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: 22329473
• Report Number: 2024168-2025-06446
• Device Sequence Number: 12837192
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: (01)08717648025969(11)241031(17)260930(10)4103174
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 4103174
• 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: 06/15/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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