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

Model Number	1013317
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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 that when the two versaturn guide wires were removed from the packaging, an abnormal area was noted approximately 45mm from the tip, the coils were broken.Therefore, the guide wires were not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that when the two versaturn guide wires were removed from the packaging, an abnormal area was noted approximately 45mm from the tip, the coils were broken.Therefore, the guide wires were not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initially filed reports, additional information was received.A picture of the guide wires noted the tip coils were stretched.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.A production scrap review and friction testing for the lot analysis reveal no indication of an issue.Based on the information provided, a definitive cause for the reported issue could not be determined.Images of the device show a break of the polymer and a stretch of the exposed coil of about 2-3mm (estimated).It is possible the coils were inadvertently damaged when the wire was removed from the coil.It is possible that when the wires were removed from the coil from the distal end of the wire, that caused the break; however, this cannot be confirmed as there was no noted difficulty removing the wires.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.A production scrap review and friction testing for the lot analysis reveal no indication of an issue.Based on the information provided, a definitive cause for the reported issue could not be determined., images of the device show a stretch/break of the exposed coil of about 2-3mm (estimated).It is possible the coils were inadvertently damaged when the wire was removed from the coil.It is possible that when the wires were removed from the coil from the distal end of the wire, that caused the break and stretch; however, this cannot be confirmed as there was no noted difficulty removing the wires.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that when the two versaturn guide wires were removed from the packaging, an abnormal area was noted approximately 45mm from the tip, the coils were broken.Therefore the guide wires were not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initially filed reports, additional information was received.A picture of the guide wires noted the tip coils were stretched.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: 23815810
• Report Number: 2024168-2025-12059
• Device Sequence Number: 10104593
• Product Code: DQX
• UDI-Device Identifier: 08717648198434
• UDI-Public: (01)08717648198434(17)270331(10)5040471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 02/19/2026

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 Model Number: 1013317
• Device Catalogue Number: 1013317
• Device Lot Number: 5040471
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/18/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/22/2026; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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
• Patient Sex: Unknown