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

Model Number	1020009
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the proximal left anterior descending (lad) coronary artery with moderate tortuosity and 90% stenosis.The turntrac guide wire was advanced to the lesion and a 2.0x15 mm sapphire balloon was advanced to the lesion and inflated after intravascular ultrasound was performed.After dilatation, an attempt was made to remove only the sapphire balloon but the turntrac guide wire was unintentionally withdrawn.It was confirmed that the wire had become stuck in the wire lumen of the sapphire balloon.A versaturn guide wire was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot of level product quality issue.It is possible that a coagulation of blood/contrast on the guide wire resulted in the reported difficult to remove; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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 # 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: 22740276
• Report Number: 2024168-2025-08194
• Device Sequence Number: 9104297
• Product Code: DQX
• UDI-Device Identifier: 08717648222627
• UDI-Public: (01)08717648222627(17)261231(10)5013071
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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 Model Number: 1020009
• Device Catalogue Number: 1020009
• Device Lot Number: 5013071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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: SAPPHIRE BALLOON.
• Patient Sex: Unknown