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

Model Number	1013317
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
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 specific issue.Based on the reported information, the investigation determined that the reported issue appears to be related to operational context of the procedure.Factors that may contribute to failure advancing the guide wire include, but are not limited to, outer diameter of the guide wire, challenging anatomy, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire.In this case, it is likely that the challenging anatomy contributed to the reported difficulty as it was reported that the guide wire tip became stuck in the anatomy during removal.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.
Event or Problem Description
It was reported that the procedure was to treat right coronary artery with moderate calcification, moderate tortuosity and 90% stenosis.The versaturn guide wire tip became stuck in the anatomy during removal.The wire was removed independently, without any fracture or separation.A non-abbott guide wire was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 24073166
• Report Number: 2024168-2026-00267
• Device Sequence Number: 13039899
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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: 12/26/2025
• Initial Report FDA Received Date: 01/14/2026
• 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