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

Model Number	1011834H
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
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.It was reported the device was used 2026-2-9 (post expiration date).It should be noted in the hi-torque wire instruction for use states: ¿refer to the device label for any additional product-specific indications that may apply.¿ the label stated the expiration date as 2026-01-31.In this case, using the wire use after the expiration date does not appear to have contributed to the difficulties.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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - use after expiration.

• 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: 24469004
• Report Number: 2024168-2026-00818
• Device Sequence Number: 15848372
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: (01)08717648116100(11)240214(17)260131(10)4021471
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 1011834H
• Device Catalogue Number: 1011834H
• Device Lot Number: 4021471
• 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: 02/14/2024
• 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: EBU 3.5 GUIDE CATHETER.; IMPELLA HEART PUMP.; TEMPORARY VENOUS PACEMAKER.; TURNPIKE.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 30 KG