MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Model Number	1009665J
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the circumflex coronary artery.The balance middle weight (bmw) guide wire was advanced to the target lesion, but met resistance with the anatomy.When the guide wire was being removed, there was resistance with the anatomy and guiding catheter and the tip broke but the guide wire remained in one piece and was able to be removed as one complete unit without intervention.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The incident information was reviewed.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 identified no other similar incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation was determined the reported difficulty to advance, difficulty to remove and tip break appear to be related to case circumstances of the procedure.In this case, the guide wire encountered resistance with the heavily calcified anatomy resulting in the difficulty to advance and the difficulty to remove.Manipulation against resistance during retraction untimely resulted in the tip break and the difficulty to remove from the guiding catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 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: 13695240
• Report Number: 2024168-2022-02351
• Device Sequence Number: 1714842
• Product Code: DQX
• UDI-Device Identifier: 08717648118760
• UDI-Public: 08717648118760
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: 12/31/2022
• Device Model Number: 1009665J
• Device Catalogue Number: 1009665J
• Device Lot Number: 1011871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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