MAUDE Adverse Event Report: ABBOTT VASCULAR 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE

Model Number	1020014
Medical Device Problem Codes	Break (1069); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid circumflex coronary artery with 70% stenosis and no calcification or tortuosity.The 014 ht turntrac was being advanced through the occlusion, but was not moving forward.It was observed that the wire was damaged and was uncoiled [unraveled].The tip was separated but remained connected.The guidewire was removed with the help of a micro catheter and a clinically significant delay in the procedure was noted.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 did not indicate a lot specific quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the 70% stenosed anatomy resulting in the reported failure to advance.Manipulation of the device and/or interaction with the anatomy and/or other devices resulted in the reported stretched coils and ultimately resulted in the reported tip break.The treatment(s) appears to be related to the operational context of the procedure as the guidewire was removed with the help of a micro catheter and a clinically significant delay in the procedure was noted.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 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 having ¿¿no calcification or tortuosity.¿ is was also described as being ¿¿70% stenosis¿¿.Based on these descriptions there it is possible that the lesion characteristics were misdiagnosed initially, potentially leading to an improper guide wire selection; i.E.A guide wire most aligned with treating a lesion requiring a higher, more robust tip load.B3, b6; dates updated.

• Brand Name: 0.014 HI-TORQUE (HT) TURNTRAC 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16438013
• Report Number: 2024168-2023-01897
• Device Sequence Number: 16928109
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: 08717648222726
• 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
• Report Date (Section B): 05/22/2023

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: 01/31/2024
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Device Lot Number: 2020461
• Was Device Available for Evaluation?: No
• 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: 05/01/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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 Age: 75 YR
• Patient Sex: Unknown