MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM HELIX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-2-6-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis as found condition: the axium device was returned for analysis within a shipping box, returned within a sealed plastic dhl shipping package, an opened axium inner pouch, a dispenser coil and within an introducer sheath.No microcatheter was returned.Damage location details: the introducer sheath found to be applied incorrectly with the wavelock facing towards the distal end of the implant coil.No damage was found with the introducer sheath.The pushwire was found to be bent at ~72.1cm from the proximal end; in addition, the pushwire was found to be bent within the introducer sheath at ~55.6cm from the distal end.The axium implant coil was found to be stretched and damaged within the introducer sheath.The distal tip was found to be broken off.No other anomalies were observed.Testing analysis: during testing, the axium implant coil was unable to advance within the introducer sheath.No further resistance testing was performed, due to the damage condition of the axium device.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the damaged found with the axium device was noticed to be consistent with ¿advancing/retracting the device against resistance¿.The axium device was returned damaged with bends to the pushwire and the implant coil stretched and damaged within the introducer sheath.A few possible causes of ¿coil resistance/stuck in catheter¿ are but not limited to tortuous anatomy, user does not maintain a continuous flush, and damage or kink to pushwire; however, the root cause of ¿ coil resistance/stuck in catheter¿ was unable to be determined.The report notes that ¿axium coil could not be pushed into the catheter, and experienced resistance.¿.No patient vessel tortuosity was mentioned.The reported echelon microcatheter was not returned; therefore, any contribution the microcatheter had towards the resistance was unable to be verified.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the axium coil could not be pushed into the catheter, and experienced resistance.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include an echelon microcatheter.

• Brand Name: AXIUM HELIX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23560177
• Report Number: 9617601-2025-02756
• Device Sequence Number: 10107717
• Product Code: KRD
• UDI-Device Identifier: 00847536037298
• UDI-Public: (01)00847536037298(17)270909(10)229539075
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K081465
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: QC-2-6-HELIX
• Device Catalogue Number: QC-2-6-HELIX
• Device Lot Number: 229539075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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 Age: 68 YR
• Patient Sex: Female