MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE PILOT GUIDE WIRE

Model Number	1010482-HJ
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
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 the procedure was to treat a lesion in the right coronary artery with heavy calcification and mild tortuosity.The 014 hi-torque pilot 200 guidewire (gw) was attempted to to advanced to the target lesion with a guide extension catheter; however, after an hour of manipulating the gw, the tip broke inside the guide catheter.Therefore, the gw, guide extension catheter and guide catheter had to be removed as a single unit.After removal the separated portion of the gw was found inside the guide catheter.Then, the procedure was continued using another hi-torque pilot gw; however, the gw was unable to cross the lesion due the anatomy.Therefore, the gw was removed from the patient without issue.There was no adverse patient effect reported and no clinically significant delay reported in the procedure.The physician decided to end the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported difficult to advance and difficult to remove could not be tested due to the device condition.The reported material separation was confirmed.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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE PILOT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 16939753
• Report Number: 2024168-2023-05213
• Device Sequence Number: 20634493
• Product Code: DQX
• UDI-Device Identifier: 08717648073908
• UDI-Public: 08717648073908
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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: 06/30/2024
• Device Model Number: 1010482-HJ
• Device Catalogue Number: 1010482-HJ
• Device Lot Number: 2072771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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