MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE TURNTRAC GUIDE WIRES

Catalog Number	1020014
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in both the anterior descending branch and the diagonal branch.The hi-torque (ht) turntrac guide wire reached the distal end of the diagonal branch without resistance while a non-abbott guide wire reached the anterior descending branch.However, after the lesions were treated, it appeared that the guide wire was under the stent and the physician used a small balloon to try to retrieve the guide wire of the pulling wire but broke.Force was applied during attempt at removal.Under intravascular ultrasound, it was found that the guide wire had the possibility of being in the stent, and finally decided to place an additional stent to compress the guide wire and finally completed the operation.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6 - medical device problem code 2017/excessive force; failure to follow steps / instructions.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported entrapment of device and device damaged by another device could not be tested as they are based on operational circumstances.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 incidents from this lot.It was reported that the force was applied to the guide wire during removal when resistance was encountered.It should be noted that the hi-torque turntrac guide wire instructions for use (ifu) states: do not: ¿push, auger, withdraw, or torque a guide wire that meets resistance.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.¿ in this case, it was reported that the force used during removal of the guide wire was due to interaction with an implanted stent.For this reason, the force applied appears to be a reasonable clinical response to the difficulties.It was reported that guide wire became entrapped with the stent post implantation.It should be noted that the hi-torque turntrac guide wire instructions for use (ifu) states: do not: ¿deploy a stent such that it will entrap the wire between the vessel wall and the stent.¿ the investigation determined the reported difficulties appear to be related to the user error.The reported treatments appear to be related to operational circumstances of the procedure.An additional stent was implanted to secure the separated wire in the vessel.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: HI-TORQUE TURNTRAC GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18314660
• Report Number: 2024168-2023-13882
• Device Sequence Number: 6115426
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: 08717648222726
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173795
• 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): 02/21/2024

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: 09/30/2024
• Device Catalogue Number: 1020014
• Device Lot Number: 2102461
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SION GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown