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

Catalog Number	1020009
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional dragonfly opstar device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported the turntrac and optical coherence tomography (oct) dragonfly opstar imaging catheter were delivered without any problems distal into the left anterior descending (lad) lesion.However, after the third successful image, removal of the dragonfly catheter was not possible, it was stuck with the turntrac guidewire.Both the turntrac and the dragonfly were removed together.The turntrac was inspected outside the patient anatomy, and it was observed that the distal tip of the turntrac was broken and it seems like the coils are not in the correct position.The turntrac was stuck in the oct dragonfly catheter.There were no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported break was not confirmed.The reported difficult to remove could not be tested due to the device condition.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment capas.The electronic lot history record (elhr) 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.In this case, analysis of the returned guide wire was unable to confirm the reported tip break.The analysis discovered misaligned coils on the distal end.This type of damage is consistent with interaction between the guide wire and the anatomy or an accessory device.It is possible that the misaligned coils impacted the clearance between the guide wire and the dragonfly optical coherence tomography (oct) catheter, resulting in the reported difficulty during removal; however, this cannot be confirmed.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 # 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: 18822347
• Report Number: 2024168-2024-02654
• Device Sequence Number: 7795888
• 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): 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/23/2024
• 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
• Patient Sex: Unknown