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

Model Number	1001311
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/12/2025
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.H6 medical device problem code: 2017 - excessive force.
Event or Problem Description
It was reported the procedure was to treat a moderately calcified and mildly tortuous lesion in the inferior mesenteric artery.A non-abbott stent was placed and the ironman guide wire tip became caught in the implanted stent during repositioning.During retraction resistance was met and force was applied, the tip then broke off.An attempt was made to snare the separated portion however was unsuccessful.A brachial cutdown was performed and another snare was advanced however was still unable to remove the separated portion.Another stent was implanted to embed the separated wire tip.There were no adverse patient sequela 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 information provided, the investigation determined that the reported resistance during removal appeared to be related to circumstances of the procedure which likely led to the reported material separation.The subsequent treatments appear to be related to circumstances of the procedure.In this case, the guide wire tip became caught in the implanted stent during repositioning that resulted in the reported resistance.It should be noted that the instructions for use (ifu) states: do not: push, auger, withdraw or torque a guide wire that meets resistance.In this case, based on the reported information, the ifu violation was circumstantial due to the difficulties experience 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.

• Brand Name: HI-TORQUE IRONMAN¿
• 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22094828
• Report Number: 2024168-2025-05428
• Device Sequence Number: 7885383
• Product Code: DQX
• UDI-Device Identifier: 08717648013652
• UDI-Public: (01)08717648013652(17)260331(10)4040862
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963702
• 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,Followup
• Report Date (Section B): 07/15/2025

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 Expiration Date: 03/31/2026
• Device Model Number: 1001311
• Device Catalogue Number: 1001311
• Device Lot Number: 4040862
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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