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

Model Number	1010480-H
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 guide wire could not cross the lesion due to the anatomy.Upon removal from the anatomy it was noted that the polymer coating was peeling.A non-abbott 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.
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 resistance was met with the moderately calcified, mildly tortuous and 80% stenosed anatomy resulting in the reported failure to advance.Interaction with the moderately calcified, mildly tortuous and 80% stenosed anatomy and/or other devices likely resulted in the reported peeled/delaminated polymer coating.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.

• 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: 23467431
• Report Number: 2024168-2025-11360
• Device Sequence Number: 18366226
• 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,Followup
• Report Date (Section B): 11/17/2025

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
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/17/2025
• 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
• Patient Sex: Unknown