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

Model Number	1005357H
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the distal left anterior descending coronary artery (dlad) with heavy calcification, heavy tortuosity and 90% stenosis.The 014 whisper ms guide wire failed to cross the lesion and the core was noted kinked.There was resistance during advancement and removal due to the anatomy.The lesion was left untreated.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
H2: updated the device identification fields to align with the information in the corresponding fields in gudid.

• 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: 18051380
• Report Number: 2024168-2023-12146
• Device Sequence Number: 12781747
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: (01)08717648037801(17)240531(10)2061571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/24/2024

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: 05/31/2024
• Device Model Number: 1005357H
• Device Catalogue Number: 1005357H
• Device Lot Number: 2061571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2022
• 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: Unknown