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

Model Number	1013317
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
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 the procedure was to treat the right coronary artery with moderate calcification, mild tortuosity and 80% stenosis.The versaturn guide wire was used in the procedure but it was noted during removal that there was resistance due to a stent.The tip coils were stuck in the mesh of the stent.After many attempts, a microcatheter was used to remove the guide wire.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Analysis was performed to the returned device.Production record and corrective and preventive action (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 information provided and the observations from the returned analysis, the investigation determined that the reported issues appear to be related to circumstances of the procedure.In this case, it was reported that the versaturn guide wire was used in the procedure and during removal there was resistance noted due to a stent.The tip coils were stuck in the mesh of the stent which likely led to the reported stretched coils and observed damages to the shaping ribbon.The observed scraped teflon coating likely occurred due to interaction with the torque device being tight against the guide wire.Cine review was performed on a returned image.Upon reviewing the image received, it is noted that the wire is beyond a stent located in the distal right coronary artery.No determination can be made as to the tip coils being entwined (stuck) in the stent as the image provided does not show the details of the stent, wire and the artery well enough to visualize any contact between the wire and the stent.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: 21912086
• Report Number: 2024168-2025-04339
• Device Sequence Number: 7313538
• Product Code: DQX
• UDI-Device Identifier: 08717648198434
• UDI-Public: (01)08717648198434(17)261130(10)4120371
• 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
• Report Date (Section B): 06/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1013317
• Device Catalogue Number: 1013317
• Device Lot Number: 4120371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown