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

Model Number	1009666
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch form received.Reported as [while stenting, wire became jailed behind stent.Wire broke while trying to remove it.] it was reported that the procedure was to treat a 90% stenosed lesion in the right posterior descending artery (rpda).The ht bmw universal ii guidewire (gw) was used in the procedure; however, the gw became jailed behind a stent.The tip of the gw became separated when firm effort was applied during removal.The patient went under open heart surgery to remove the jailed tip of the gw at another facility.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Actual patient weight 111.6 kg.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported entrapment of device could not be tested as it was based on operational context.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported that a force was applied when resistance was encountered during removal of the guide wire from the anatomy.It should be noted that the hi-torque guide wires for ptca, pta, stents instructions for use states: ¿do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.¿ although it was noted the physician used force to remove the device from the anatomy, this was due to the guide wire becoming entrapped behind a previously implanted stent.The force applied during removal seems to be a reasonable clinical response to the difficulties.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.In this case, it was reported that the guide wire interacted with a previously implanted stent, resulting in the guide wire becoming entrapped/jailed behind the stent.Manipulation of the guide wire subsequent to its entrapment, likely resulted in the reported separation.Additionally, the patient underwent surgery to remove the separated tip from the anatomy.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: 16709956
• Report Number: 2024168-2023-03663
• Device Sequence Number: 12282008
• Product Code: DQX
• UDI-Device Identifier: 08717648118739
• UDI-Public: 08717648118739
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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 Expiration Date: 06/30/2024
• Device Model Number: 1009666
• Device Catalogue Number: 1009666
• Device Lot Number: 2072871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 112 KG