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

Model Number	1005359H
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
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 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 interaction with the previously implanted stents resulted in the reported failure to advance and the reported difficult to remove leading to proximal retraction of the stents.As reported, the stents no longer overlapped appropriately, leaving a gap between them.An additional unspecified stent over the non-abbott guidewire, was subsequently implanted to bridge the gap.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.
Event or Problem Description
It was reported that the procedure performed was to treat a stenosed, mildly calcified, mildly tortuous left superficial femoral artery (sfa) that is 100% stenosed.The patient presented with in-stent restenosis of previously implanted unspecified stents through sfa.A non-abbott guide wire was used alongside the 014 whisper ms guide wire as a buddy wire.During advancement, the whisper guide wire met resistance with the previously implanted stents and could not cross.During removal, the whisper guide wire met resistance with the implanted stents, leading to proximal retraction of the stent.As a result, the stents no longer overlapped appropriately, leaving a gap between them.An additional unspecified stent was implanted to bridge the gap.A 5.0x20mm armada 35 balloon was inserted over the non-abbott guide wire and inflated to hold the stent in place.Once inflated and stent was stabilized, the whisper guide wire was able to be removed.There were no adverse patient effects and 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: 25860308
• Report Number: 2024168-2026-02851
• Device Sequence Number: 12060499
• Product Code: DQX
• UDI-Device Identifier: 08717648037825
• UDI-Public: (01)08717648037825(11)260424(17)280331(10)6042471
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/17/2026

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: 1005359H
• Device Catalogue Number: 1005359H
• Device Lot Number: 6042471
• 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: 06/25/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2026
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White