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

Model Number	1011834H
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a chronic total occlusion in the right coronary artery (rca) and heavily calcified and mildly tortuous lesion in the left anterior descending (lad) artery.An impella heart pump was placed along with a temporary venous pacemaker.An ebu 3.5 guide catheter was inserted into the left main (lm) artery and then a non-abbott black wire was inserted into the proximal lad.A turnpike was inserted over the black wire trying to cross the right lesion in the mid lad.The wire was exchanged for an extra support whisper wire however it failed to cross the lesion and was removed.A second whisper guide wire was inserted however failed to cross the lesion and was removed.When taking an angiogram a perforation was noted.Per the physician, the second whisper guide wire was too aggressive for the lesion; resulting in the perforation.The decision was made to watch the patient who was hemodynamically stable.The procedure was aborted to let the perforation heal.Patient then had to have a pericardiocentesis to remove fluid from the pericardium.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.Cine images were received and reviewed by an abbott clinical specialist.In the images provide, the lad is heavily diseased throughout the vessel including the main vessel and the diagonals.It has heavy calcification as indicated in the incident description.The images provided do not show the guide wire visualized within the vessel.There is blushing around the vessel which indicates leaking of blood into the surrounding tissue which confirms the perforation.The source of the perforation cannot be confirmed but it is reasonable to expect that the guide wire caused or contributed to the perforation.The whisper es does have a higher tip load than some other guide wires.It is often used to traverse calcification or thick lesion material.The vessel imaged appear friable and heavily diseased which would contribute to the ease of perforation.The reported patient effect of perforation is listed in the hi-torque wire instruction for use as a known potential patient effect associated with the use of a wire in coronary or peripheral arteries and / or biliary tree.Based on the information received, the investigation determined that the reported issue appears to be related to operational context.It was reported the lesion was heavily calcified which likely contributed to the failure to advance.The vessel appeared friable.In this case, it is possible the patient anatomy and wire support contributed to the perforation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 24468962
• Report Number: 2024168-2026-00817
• Device Sequence Number: 13339197
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: (01)08717648116100(11)250813(17)270731(10)5081372
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 02/27/2026

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: 1011834H
• Device Catalogue Number: 1011834H
• Device Lot Number: 5081372
• 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: 02/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EBU 3.5 GUIDE CATHETER; IMPELLA HEART PUMP; TEMPORARY VENOUS PACEMAKER; TURNPIKE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 30 KG