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

Model Number	1005357HJ
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that upon opening the whisper guide wire, the device was noted to be broken/bent.There was no device use or patient involvement.Another unspecified guide wire was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Analysis was performed to the returned device.The reported break was not confirmed.The reported bent was observed as a kink in the core.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 specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported issues could not be determined.Factors that may contribute to damages observed during packaging include, but are not limited to, damage incurred during manufacturing, damage incurred during shipment, or inadvertent mishandling during unpacking or preparation.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 22046589
• Report Number: 2024168-2025-05213
• Device Sequence Number: 8880300
• Product Code: DQX
• UDI-Device Identifier: 08717648037818
• UDI-Public: (01)08717648037818(11)240122(17)251231(10)4012271
• 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,Followup
• Report Date (Section B): 07/02/2025

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: 12/31/2025
• Device Model Number: 1005357HJ
• Device Catalogue Number: 1005357HJ
• Device Lot Number: 4012271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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
• Patient Sex: Female