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

Model Number	1020013
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified left anterior descending artery.A turntrac guide wire was advanced and placed distally.The vessel was pre-dilatated, stented and post dilatated after the stent was deployed.During removal of the guide wire the wire elongated and the coils began to elongate as well.The tip of the wire still remained in the distal lad where it was placed while still attempting to remove the coil stretched till the radial sheath of the patient.Resistance was felt as the tip remain stuck in the distal lad; however, as the guide wire was being pulled out it separated from the radial sheath.The tip remained inside the patient's artery.There was no clinically significant delay reported.No additional information was provided.
Event or Problem Description
Subsequent to the previously file report, additional information was provided that an unspecified balloon used to embed the tip to the vessel wall.There was no adverse patient sequela, no additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported stretching, material separation, and break were confirmed.The reported difficult to remove 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/complaints from this lot.In this case, return device analysis confirmed that the outer diameter of the guide wire is within specification.This indicates a product quality issue did not contribute to the reported difficult to remove.It was reported that the guide wire interacted with the patient¿s anatomy, becoming stuck in the distal lad, resulting in the reported difficult to remove.The guide wire was manipulated in an attempt to remove it from the anatomy, likely resulting in the reported stretched coils and subsequent coil/solder separation.Additionally, the separated portion of the guide wire was embedded into the vessel wall.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.D4: correction - updated lot number.H6: correction - device codes 2687, 4614 were removed and replaced with 3165 and 4641.

• 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: 17204536
• Report Number: 2024168-2023-06798
• Device Sequence Number: 14837799
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/21/2023

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: 07/31/2024
• Device Model Number: 1020013
• Device Catalogue Number: 1020013
• Device Lot Number: 2082261
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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; Other
• Patient Sex: Unknown