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

Model Number	1011835H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
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 a severely calcified, mildly tortuous mid left anterior descending artery.A whisper guidewire was inserted but caused a perforation.The perforation was treated with balloon tamponade technique.The procedure was aborted.The patient was hospitalized.The physician believed the interaction with the heavy calcium caused the perforation.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.Production record and corrective and preventative actions (capa) records were reviewed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling system for the reported lot was performed and revealed no indication of a lot specific product quality issue.A conclusive cause for the reported patient effects, perforation of vessels, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect of perforation of vessels is listed in the hi-torque guide wires instruction for use as a known patient effect of coronary procedures.Based on the reported information and results of the complaint investigation, there is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: HI-TORQUE WHISPER¿
• 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: 23975666
• Report Number: 2024168-2026-00095
• Device Sequence Number: 4630929
• Product Code: DQX
• UDI-Device Identifier: 08717648116117
• UDI-Public: (01)08717648116117(11)250707(17)270630(10)5070771
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1011835H
• Device Catalogue Number: 1011835H
• Device Lot Number: 5070771
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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 Age: 79 YR
• Patient Sex: Male