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); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/02/2025
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 left circumflex coronary artery with heavy calcification and heavy tortuosity.The ironman guide wire was advanced to the lesion and two xience stents were deployed without issue.The guide wire was being removed; however, it was noted that the tip was knotted and stuck on the end of the deployed 3.5x18 mm xience skypoint stent.A microcatheter was used in an attempt to remove the guide wire but the tip separated and was left on the edge of the deployed stent.The tip was ballooned into the xience stent and left in the patient.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported tip knot was not confirmed as a portion of the separated tip was not returned.The reported device entrapment was not confirmed, and it could not be replicated in a testing environment as it was based on operational circumstances.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 tip damage and resistance appear 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 that resulted in the reported resistance and led to the tip separation.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: 22321071
• Report Number: 2024168-2025-06422
• Device Sequence Number: 8988439
• Product Code: DQX
• UDI-Device Identifier: 08717648013652
• UDI-Public: (01)08717648013652(17)261031(10)4110562
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 1001311
• Device Catalogue Number: 1001311
• Device Lot Number: 4110562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5X18 MM XIENCE SKYPOINT STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 66 KG