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

Model Number	1001780-HC
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.It was reported that the guidewire was inadvertently advanced into the small branch of the left circumflex artery (lcx), resulting in the wire becoming entrapped.Additionally, it was stated that after attempted removal, the coils were observed to be unraveled (core break).It is likely that manipulation of the wire, when resistance was encountered, contributed to the unraveled coils (core break).There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported the procedure was to treat a stenosed lesion in the proximal left circumflex (lcx) artery.The bmw hydro guide wire was advanced to the target lesion followed by balloon dilatation to prep the lesion.An attempt was made to recross the guide wire however the distal tip was trapped in a small branch of the lcx.An second attempt was made to pull the guide wire however it did not move at all and it was noted the coils were unraveled.A balloon catheter was advanced and inflated at the tip of the guiding catheter to entrap the guide wire between the balloon and inner wall of the guiding catheter.The guide wire was pulled gently and was able to be removed from the patient.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: 21546314
• Report Number: 2024168-2025-02412
• Device Sequence Number: 6934567
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: (01)08717648025969(17)260731(10)4080571
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Report Date (Section B): 03/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 4080571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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