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

Model Number	1005357HJ
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.A cine was received and reviewed by an abbott vascular clinical specialist: it was reported that while treating the cx artery, a whisper ms guidewire was positioned in both the lad and cx.It was noted that both wires moved together as if being pulled simultaneously due to sticking when only one guidewire was being retracted.It was also noted that an nc trek neo balloon was advanced and inflated successfully but during a second inflation attempt at the bifurcation, the balloon was unable to re-cross the vessel/stent and a new balloon was used to complete the procedure.The provided media (img 2647) shows wires positioned in the cx and lad.There is a stent placed in the lad and a non-inflated balloon positioned within the stent.A cause for both the wires moving together and the failure of the balloon to re cross the stent cannot be determined by the provided media.It is possible that interaction between both guidewires, other devices and/or a coagulation of blood/contrast on the guidewire(s) resulted in the reported difficult to remove; however, as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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.The additional device referenced in b5 & d10 is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the circumflex (cx) artery with moderate calcification and mild tortuosity.The whisper ms guidewire was positioned in the cx artery and another whisper ms guidewire was in the left anterior descending (lad) artery.Both guidewires were noted to move together as if being pulled simultaneously due to sticking when only one guidewire is being retracted.The guidewire was still removed independently and used successfully.An nc trek neo balloon was advanced and inflated successfully; however, during a second inflation attempt to use the balloon at the bifurcation, the balloon was unable to re-cross the vessel/stent due to the crossing profile of the balloon.A new balloon had to be opened to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 22867420
• Report Number: 2024168-2025-08817
• Device Sequence Number: 18469792
• Product Code: DQX
• UDI-Device Identifier: 08717648037818
• UDI-Public: (01)08717648037818(11)241114(17)261031(10)4111471
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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 Model Number: 1005357HJ
• Device Catalogue Number: 1005357HJ
• Device Lot Number: 4111471
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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: NC TREK NEO BALLOON; WHISPER MS GUIDEWIRE
• Patient Sex: Unknown