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

Model Number	1010480-H
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
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 review of the complaint handling database identified no other similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that device interaction as the reported attempt to move the guide wire while the balloon was pressurized/inflated resulted in the reported difficult to remove.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.
Event or Problem Description
It was reported that the procedure was to treat the left circumflex coronary artery with moderate calcification, mild tortuosity and 80% stenosis.The hi torque pilot 50 guide wire was advanced to the lesion.The lesion was then pre-dilated with a 2.5x12 mm semi-compliant balloon.The balloon was attempted to be removed but it was stuck with the guide wire so the devices were removed together.Another pilot guide wire was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 23469528
• Report Number: 2024168-2025-11373
• Device Sequence Number: 15655179
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: (01)08717648073854(11)241009(17)260930(10)4100971
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: 1010480-H
• Device Catalogue Number: 1010480-H
• Device Lot Number: 4100971
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.5X12 MM SEMI COMPLIANT BALLOON
• Patient Sex: Unknown