MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 14 GUIDE WIRE

Model Number	2078173
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a chronic total occlusion (cto) in the posterior tibial artery with moderate calcification, heavy tortuosity and 100% stenosis.The ht command 14 guide wire crossed the lesion from the anterior tibial artery (ata) via retrograde approach, but an unspecified balloon catheter failed to cross the lesion.Therefore, the ht command 14 was being removed, but the tip became stuck in the lesion.A non-abbott micro catheter was replaced with another.018 non-abbott catheter to remove the guide wire.Force was applied; however, the tip was separated and remains in the patient's anatomy.The tip was possibly embedded in the lesion, but this could not be confirmed.There were no adverse patient sequela.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.Device code 2017 - excessive force.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation could not be tested due to the device condition.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.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported that a force was applied during removal of the guide wire from the anatomy.It should be noted that the command es instructions for use states: ¿do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.¿ in this case, it was noted that the guide wire encountered resistance with the lesion during removal, therefore, the force applied during removal seems to be a reasonable clinical response to the difficulties.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.In this case, it was noted that the guide wire interacted with the moderately calcified, heavily tortuous, and 100% stenosed lesion, resulting in the reported entrapment.Manipulation of the entrapped wire, as use of force was noted, likely resulted in the reported material separation.The separated portion of the guide wire was possibly embedded in the lesion, but this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE COMMAND 14 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: 17219755
• Report Number: 2024168-2023-06903
• Device Sequence Number: 3034714
• Product Code: DQX
• UDI-Device Identifier: 08717648176661
• UDI-Public: 08717648176661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122573
• 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): 08/03/2023

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: 12/31/2024
• Device Model Number: 2078173
• Device Catalogue Number: 2078173
• Device Lot Number: 3012571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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: Other
• Patient Sex: Unknown