BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACT CATHETER

    MDR report key: 22968357 · Received September 4, 2025

    Report

    Report Number
    2029214-2025-01968
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 21, 2025
    Report Date
    September 4, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    QJP
    UDI-DI
    00847536031784
    PMA / PMN Number
    K182097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS AS FOUND CONDITION: THE REACT-71 CATHETER WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, A PLASTIC BIO-POUCH, AN OPEN REACT-71 INNER POUCH (D011097), AND A DISPENSER COIL. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGE WAS FOUND WITH THE REACT-71 CATHETER HUB. THE REACT-71 CATHETER BODY WAS FOUND STRETCHED FROM ~11.0CM TO ~2.0CM FROM THE CATHETER DISTAL TIP. THE REACT-71 CATHETER BODY WAS FOUND RUPTURED AT ~7.0CM FROM THE CATHETER DISTAL TIP. WHAT APPEARS TO BE A COATING DEFECT/BUMP WAS FOUND ON THE REACT-71 CATHETER OUTER DIAMETER AT ~4.8CM FROM THE CATHETER DISTAL TIP. THE REACT-71 CATHETER BODY WAS FOUND STRETCHED AT ~2.0CM FROM THE CATHETER DISTAL TIP. THE REACT-71 CATHETER DISTAL MARKER/TIP WAS FOUND DAMAGED. UPON EXAMINATION, WHAT APPEARS TO BE LOOSE WIRE WAS OBSERVED WITHIN THE DISTAL ~2.0CM OF THE REACT-71 CATHETER LUMEN. TESTING/ANALYSIS: THE REACT-71 CATHETER WAS DISSECTED. AND THE INNER LINER WAS FOUND TO BE TORN WITH THE INNER WIRE DISLODGED AT ~2.0CM FROM THE DISTAL TIP. ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿CATHETER KINK/DAMAGE¿ REPORT WAS CONFIRMED AS THE REACT-71 CATHETER BODY WAS FOUND STRETCHED AT ~2.0CM FROM THE CATHETER DISTAL TIP WITH THE INNER LINER TORN AND INNER WIRE DISLODGED. POSSIBLE CAUSES OF CATHETER DAMAGE INCLUDE PATIENT VESSEL TORTUOSITY, EXCESSIVE RESISTANCE THAT CAN COMPROMISE INNER LAYERS OF THE CATHETER COILS, OR INCOMPATIBLE DEVICES. HOWEVER, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. REGARDING THE CATHETER BODY RUPTURE, COATING DEFECT/BUMP, AND DAMAGED DISTAL MARKER/TIP THE CAUSE OF THESE DAMAGE COULD NOT BE DETERMINED AS THESE ISSUES WERE NOT REPORTED BY THE CUSTOMER. 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 AFTER ANGIOGRAPHY, THE PATIENT WAS SUSPECTED OF ACUTE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY. THE SURGEON CONSIDERED USING A DISPOSABLE INTRACRANIAL THROMBUS ASPIRATION CATHETER REACT-71 + THROMBECTOMY STENT TO PERFORM SWIM THROMBECTOMY FOR THE PATIENT. UNDER THE GUIDANCE OF THE MICROCATHETER REBAR-18 AND THE GUIDEWIRE AVIGO, REACT-71 SUCCESSFULLY REACHED THE PROXIMAL END OF THE OCCLUDED LESION SEGMENT, AND THE SOLITAIREX INTRACRANIAL THROMBECTOMY STENT SFR4-6-40-10 WAS SELECTED FOR IMPLANTATION. AFTER THE STENT WAS OPENED AND OBSERVED FOR 5 MINUTES, THE FIRST STENT THROMBECTOMY WAS PERFORMED UNDER THE CONTINUOUS NEGATIVE PRESSURE OF THE 20ML SYRINGE. WHEN THE REACT-71 AND THE THROMBECTOMY STENT WERE WITHDRAWN FROM THE BODY, THE SURGEON FOUND THAT THE TIP OF THE REACT-71 CATHETER WAS OBVIOUSLY NARROWED AND DEFLATED AT ABOUT 1.5CM, AND THE ENTIRE TIP OF THE CATHETER WAS NOT SMOOTH. CONSIDERING THE SAFETY OF THE SUBSEQUENT OPERATION, THE SURGEON IMMEDIATELY REPLACED THE CATHETER WITH ANOTHER REACT-71 CATHETER FOR THE SUBSEQUENT OPERATION AND REQUESTED THAT THE FIRST REACT-71 BE COMPLAINED ABOUT WITHOUT CHARGE. AFTER THE OPERATION W AS SUCCESSFULLY COMPLETED, THE PATIENT RETURNED TO THE WARD SAFELY FOR OBSERVATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING THROMBECTOMY SURGERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF ABOUT 7MM. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. IT WAS ALREADY SHRUNKEN WHEN PULLED IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852079 REACT CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MICRO THERAPEUTICS, INC. DBA EV3 REACT-71 D011097 00847536031784

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male