MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE TURNTRAC; WIRE, GUIDE, CATHETER

Model Number	1020014
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
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.
Event or Problem Description
It was reported the procedure was to treat a moderately calcified and tortuous lesion in the left anterior descending artery.Resistance was met removing the ht turntrac guide wire.When removed from the anatomy the coils were noted to be unraveled.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported break was confirmed.The reported difficult to advance could not be tested due to the device condition.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.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.It was reported that resistance was encountered when attempting to remove the guide wire from the anatomy, resulting in the coils becoming unraveled (break).Factors that may contribute to difficulty removing the guide wire include, but are not limited to, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire.In this case, it is possible that the patient¿s moderately calcified and moderately tortuous lesion contributed to the resistance; however, this cannot be confirmed.Additionally, analysis of the returned wire confirmed the reported core break and noted coils stretching.The break was located at the intermediate solder, between the shaping ribbon and core.This type of damage can occur when the shaping ribbon encounters resistance, and the core is pulled.It is possible that manipulation of the wire, when resistance was met, contributed to the break and coil damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE TURNTRAC
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19825481
• Report Number: 2024168-2024-08809
• Device Sequence Number: 8679514
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: (01)08717648222726(17)241231(10)3010961
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/13/2024

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: 12/31/2024
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Device Lot Number: 3010961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 49 KG
• Patient Race: Asian