BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE

    MDR report key: 22438533 · Received July 8, 2025

    Report

    Report Number
    2029214-2025-01536
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MJN
    UDI-DI
    00763000294403
    PMA / PMN Number
    K101570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID APB-2-2-HX-ES (LOT: 229795530); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID APB-2-2-HX-ES (LOT: 229795530); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID APB-1.5-3-HX-ES (LOT: 229655947); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID APB-1.5-3-HX-ES (LOT: 229655947); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID APB-1-3-HX-ES (LOT: 230574176); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 145-5091-150 (LOT: D029354); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT, ACCORDING TO THE DOCTOR, THE FIVE (5) AXIUM COILS DID NOT PROGRESS IN THE ECHELON CATHETER HUB. IT WAS ALSO REPORTED THAT THEY HAD PROBLEMS WITH THE HYPERGLIDE BALLOON; THE DOCTOR REPORTED THAT THE HYPERGLIDE BALLOON WAS PUNCTURED. ULTIMATELY, THEY DECIDED NOT TO PERFORM THE INTERVENTION ON THE PATIENT DUE TO THE INCIDENT. THE REPORTED CATHETER WAS PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). STILL, IT WAS UNKNOWN WHETHER THE COILS AND THE HYPERGLIDE BALLOON WERE PREPARED AS INDICATED IN THE IFU.  THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL DID NOT PASS THROUGH THE ECHELON HUB. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE WAS OBSERVED TO THE COILS AFTER REMOVAL. TRIED TO INSERT AVIGO AND IT PASSED NORMALLY, ONLY THE COIL DIDN'T PASS. THE BALLOON WAS PUNCTURED. THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE. IN THE TEST PROBLEMS PRESENTED. THE GUIDEWIRE TIP WAS ADVANCED 10CM OUT OF THE CATHETER TIP DURING INFLATION AS DIRECTED. CONTRAST RATIO WAS 50/50 THE PHYSICIAN DID NOT SHAPE THE GUIDEWIRE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857144 HYPERGLIDE CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN MICRO THERAPEUTICS, INC. DBA EV3 104-4127 B668782 00763000294403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.