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

Model Number	1013317
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, heavily calcified, heavily tortuous left anterior descending coronary artery.Once at the lesion, the 014 hi-torque versaturn guidewire got caught on a previously deployed stent and the guidewire tip kinked.An unspecified device was used to complete the procedure.There were no adverse patient effects and 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 specific issue.Based on the reported information, the investigation determined that the reported issues appear to be related to circumstances of the procedure.In this case, once the guide wire was at the lesion, the guide wire got caught on a previously deployed stent and the guide wire tip kinked.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: HI-TORQUE VERSATURN¿
• 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: 23021985
• Report Number: 2024168-2025-09665
• Device Sequence Number: 13217598
• Product Code: DQX
• UDI-Device Identifier: 08717648198434
• UDI-Public: (01)08717648198434(17)260630(10)4071671
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141782
• 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
• Report Date (Section B): 09/10/2025

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 Expiration Date: 06/30/2026
• Device Model Number: 1013317
• Device Catalogue Number: 1013317
• Device Lot Number: 4071671
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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