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
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 catheter encountered resistance during advancement 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 wire's coating was observed to be peeling once removed from the anatomy.In this case, its 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.
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified and tortuous lesion in the left anterior descending (lad) artery.After a 3cm.014 ht whisper guidewire (gw) was advanced to the lesion, a 3.0x12mm nc trek balloon dilatation catheter(bdc) was attempted to be advanced over the gw; however, the gw was noted to be sticky [resistance during advancement] and subsequently the coating was noted to be peeled.The gw was replaced with a new.014 whisper gw, but the same issue persisted.Therefore, the whisper gw was replaced with a non-abbott gw and the same bdc was traversed over the new gw successfully, and the procedure was completed.There were no adverse patient effects nor clinical delay.No additional information weas 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: 21883830
• Report Number: 2024168-2025-04181
• Device Sequence Number: 14313245
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: (01)08717648116100(11)240826(17)260731(10)4082671
• 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
• Report Date (Section B): 04/22/2025

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 Expiration Date: 07/31/2026
• Device Model Number: 1011834H
• Device Catalogue Number: 1011834H
• Device Lot Number: 4082671
• 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: 04/01/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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: BALLOON DILATATION CATHETER(BDC): 3.0X12MM NC TREK.
• Patient Sex: Unknown