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

Model Number	1011834H
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed de novo lesion in the left anterior descending (lad) artery with mild calcification and mild tortuosity.The 3.5 x 12 mm nc trek balloon dilatation catheter (bdc) was attempted to be advanced on a whisper guide wire (gw); however, the gw was not able to track the bdc as the wire felt too sticky.The coating of the wire core was peeling during removal of the gw.Another whisper gw was attempted; however, the same issue occurred.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B5: the additional hi-torque whisper guide wire referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.It was reported that a balloon dilatation catheter encountered resistance when advancing over the wire.Factors that may contribute to difficulty advancing a balloon catheter over the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the catheter or guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulty during advancement.Additionally, it was reported that the core was observed to be peeling after removal.It is possible that manipulation of the wire, when resistance was encountered, contributed to the reported peeling, however, this cannot be confirmed.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.D9 - device available for evaluation updated from yes to no.

• 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: 21922342
• Report Number: 2024168-2025-04404
• Device Sequence Number: 12940193
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: (01)08717648116100(11)241108(17)261031(10)4110871
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 05/20/2025

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: 1011834H
• Device Catalogue Number: 1011834H
• Device Lot Number: 4110871
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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: 3.5X12MM NC TREK BALLOON
• Patient Sex: Unknown