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

Model Number	1009666J
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with heavy calcification and heavy tortuosity.After stenting and removing the balloon, during removal of the hi-torque (ht) balance middleweight universal ii guide wire, the guidewire became stuck in the posterior lateral branch of the rca.After a few attempts of pulling the guidewire with slight force, it unraveled as it was removed from the guide catheter.The radiopaque tip of the guidewire was visible on angiogram in the distal portion of the rca extending throughout the entire vessel.An attempt was made to remove the lost piece of guidewire; however, it was unsuccessful.The patient was kept an additional night in the hospital to return to the cath lab the next day as the physician requested help from another physician and needed additional supplies.Multiple attempts were made to remove the guidewire with a snare device and the additional supplies but the attempts were unsuccessful and the guidewire was left free-floating in the patient anatomy.The physician thinks the guidewire broke off at the radiopaque weld and unraveled in the vessel as it was pulled out of the guide catheter.The patient will be on dual antiplatelet drug therapy (dapt) for the rest of her life.No additional information was provided.
Additional Manufacturer Narrative
Lot number - unknown as it was not provided by the account.Medical device problem code 2017 - excessive force.The product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product were not performed because the lot number was not reported.It was reported that the guide wire was attempted to be removed from the anatomy with slight force when resistance was met.It should be noted that the hi-torque guide wires instructions for use states: do not push, auger, withdraw or torque a guide wire that meets resistance.Although it was noted the physician used slight force in the attempts to remove the device, this was due to the guide wire interacting with the patient¿s anatomy, therefore, the force applied during removal of the device appears to be a reasonable clinical response to the difficulty.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure.Additionally, the separated portion of the guide wire was unable to be removed from the anatomy and remains free-floating.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 16174100
• Report Number: 2024168-2023-00537
• Device Sequence Number: 2571071
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: 08717648118777
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1009666J
• Device Catalogue Number: 1009666J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG