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

Model Number	1020013
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Separation (1562); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a soft lesion in the left anterior descending (lad) coronary artery.The patient had st elevated myocardial infarction (stemi).The 014 ht turntrac device was being advanced through the occlusion, when it became stuck and was not able to move forward.A balloon and a new guide wire were used to dilate the lesion in order to be able to withdraw the turntrac guide wire.After being removed, the distal tip was noted to be separated.The coils were stretched and the wire was damaged.Another non-abbott wire was used to complete the procedure.A clinically significant delay was noted due to the need for balloon intervention.No additional information was provided.
Additional Manufacturer Narrative
The device is returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material separation and stretched coils were confirmed.The reported entrapment of device and failure to advance 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 other incidents from this lot.As reported, upon sudden resistance being noted when advancing the guide wire the physician utilized additional guide wires and balloons to remove the initial guide wire.Without detailed information as to the step-by-step process utilized to dislodge the ¿stuck¿ guide wire it cannot be determined if the guide wire was damaged prior to this removal process or if the removal process damaged the guide wire.The instructions for use also provides the following warnings concerning the guide wire: ¿carefully observe the instructions under ¿do not¿ and ¿do¿ below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Do not: push, auger, withdraw, or torque a guide wire that meets resistance.Torque a guide wire if the tip becomes entrapped within the vasculature.¿ the investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer stated ¿the images provided do show what appears to be a portion of a guide wire in the subject vessel.While the lesion under treatment was described as ¿soft¿ is was also described as being a ¿total occlusion¿.Based on these descriptions there it is possible that the lesion characteristics were misdiagnosed initially, potentially leading to a more aggressive treatment plan and improper guide wire selection.: medical device problem code 1069 removed.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material separation and stretched cols were confirmed.The reported entrapment of device and failure to advance 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 other incidents from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.In this case, it is likely that the stent delivery system interacted with the patient¿s lesion during advancement, resulting in the reported failure to advance and subsequent entrapment.Additionally, return device analysis noted that the separated tip¿s core was kinked at multiple location and the coils were mangled/misaligned.This indicates that the guide wire was likely manipulated after becoming entrapped, resulting in the reported tip separation, and stretched coils.The instructions -for-use (ifu) provides the following warning: ¿use the most suitable guide wire for the lesion being treated.¿ as reported, upon sudden resistance being noted when advancing the guide wire, additional guide wires and balloons were utilized to remove the initial guide wire.Without detailed information as to the step-by-step process utilized to dislodge the ¿stuck¿ guide wire it cannot be determined if the guide wire was damaged prior to this removal process or if the removal process damaged the guide wire.In this case, it is likely that the guide wire interacted with the patient¿s lesion during advancement, resulting in the reported failure to advance and subsequent entrapment.Additionally, return device analysis noted that the separated tip¿s core was kinked at multiple location and the coils were mangled/misaligned.This indicates that the guide wire was likely manipulated after becoming entrapped, resulting in the reported tip separation, and stretched coils.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 16438196
• Report Number: 2024168-2023-01898
• Device Sequence Number: 7401293
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023

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: 12/31/2023
• Device Model Number: 1020013
• Device Catalogue Number: 1020013
• Device Lot Number: 2011761
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 04/13/2023; 07/11/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/08/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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
• Patient Sex: Unknown