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

Catalog Number	1020009
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Material Separation (1562); Material Too Soft/Flexible (4007)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Foreign Body In Patient (2687)
Date of Event	01/25/2024
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 moderately calcified right coronary artery that is 50-75% stenosed.The 014 ht turntrac flex guide wire was placed in the distal area of the vessel.A 2.0x15mm balloon was delivery over the turntrac guide wire; however, before the balloon was dilated, the guide wire was no longer in the correct position.When attempting to reposition it the tip of guide wire could not longer be controllable; therefore, the balloon and guide wire had to be removed together.Once outside of the anatomy, it was observed that the distal tip of the guide wire was broken (coils and coating), and guide wire pieces [coating] were noted on the balloon.Contrast medium accumulation was noted in x-ray, which suggested a perforation.An unknown stent was placed to seal the perforation.A clinically significant delay in the procedure was noted.No additional information was provided.
Event or Problem Description
Subsequently, after the initial report was filed, it was noted that the coils did separate into separate pieces; however, no separated pieces remained in the patient.Returned device analysis confirmed that there was no coating missing.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported material too soft / flexible could not be tested as it was based on operational context.The lot history record (lhr) revealed no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties or patient effect; however, the subsequent treatment appears to be related to the operational context of the procedure.In this case, analysis of the returned guide wire noted the core separated at the intermediate solder, leaving remnants of solder.This type of damage is consistent with force applied at a solder joint.It is possible that during manipulation of the wire, it interacted with challenging anatomy or an accessory device, resulting in the reported material separation.Damage to the guide wire would impact its maneuverability, possibly contributing to the reduced support experienced during use.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code 1069 removed.

• 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 # 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: 18717412
• Report Number: 2024168-2024-01894
• Device Sequence Number: 6271543
• Product Code: DQX
• UDI-Device Identifier: 08717648222627
• UDI-Public: (01)08717648222627(17)251130(10)3121671
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/25/2024

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: 11/30/2025
• Device Catalogue Number: 1020009
• Device Lot Number: 3121671
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.5X15MM NC EMERGE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown