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

Model Number	1010482-H
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a heavily calcified totally occluded lesion in the left anterior descending (lad) artery.Multiple non-abbott guide wires were attempted however failed to cross the lesion.During advancement of the pilot guide wire resistance was met with the anatomy.During rotation and withdrawal resistance was met with the anatomy and the distal portion of the guide wire separated and remained in the coronary artery.Attempts were made to remove the separated portion with a snare device however were unsuccessful.The patient was transferred to another hospital.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.Factors that may contribute to difficult to advance and difficult to remove include but are not limited to outer diameter of the guide wire, challenging anatomy, device support, buildup of procedural contaminants, and/or user technique, and/or damage to the guide wire.In this case, it is likely that the challenging anatomy contributed to the reported difficulties as it was reported that the guide wire used to advanced through and removed from a chronic total occlusion with calcification lesion which likely led to the reported material separation.Based on the information provided, a definitive cause for the reported difficulty could not be determined.The subsequent treatment appears to be related to circumstances of the procedure.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.

• Brand Name: HI-TORQUE PILOT¿
• 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: 23606080
• Report Number: 2024168-2025-11659
• Device Sequence Number: 13202868
• Product Code: DQX
• UDI-Device Identifier: 08717648073892
• UDI-Public: (01)08717648073892(11)250314(17)270228(10)5031471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 1010482-H
• Device Catalogue Number: 1010482-H
• Device Lot Number: 5031471
• 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: 11/11/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown