BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 15216623 · Received August 12, 2022

    Report

    Report Number
    3004939290-2022-02664
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 17, 2022
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    UDI-DI
    10862028000403
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, TWO 5F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD'S) FAILED TO DEPLOY. MANUAL COMPRESSION WAS HELD FOR LESS THAN 30 MINUTES TO OBTAIN HEMOSTASIS. NO INJURY WAS REPORTED TO THE PATIENT. THE DEVICES WERE STORED AND PREPPED ACCORDING TO THE IFU. THE DEVICE WAS USED IN A DIAGNOSTIC PERIPHERAL NEUROLOGICAL PROCEDURE USING A RETROGRADE APPROACH. THE USER WAS CERTIFIED IN THE USE OF THE MYNX VCD. THE VCD WAS USED WITH A NON-CORDIS 5F SHEATH. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THE SEALANT WAS NEVER DEPLOYED. 191288-1: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HIS TORY RECORD (PHR) REVIEW OF LOT F2209401 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿SEALANT FAILURE TO DEPLOY¿ WERE NOT CONFIRMED IN EITHER OF THE DEVICES AS THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PATIENT OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, USERS ARE INSTRUCTED NOT TO USE THE DEVICE IF IT APPEARS DAMAGED IN ANY WAY. NEITHER THE PHR REVIEW NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, TWO 5F MYNX GRIP VASCULAR CLOSURE DEVICES (VCD'S) FAILED TO DEPLOY. MANUAL COMPRESSION WAS HELD FOR LESS THAN 30 MINUTES TO OBTAIN HEMOSTASIS. NO INJURY WAS REPORTED TO THE PATIENT. THE DEVICES WERE STORED AND PREPPED ACCORDING TO THE IFU. THE DEVICE WAS USED IN A DIAGNOSTIC PERIPHERAL NEUROLOGICAL PROCEDURE USING A RETROGRADE APPROACH. THE USER WAS CERTIFIED IN THE USE OF THE MYNX VCD. THE VCD WAS USED WITH A NON-CORDIS 5F SHEATH. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THE SEALANT WAS NEVER DEPLOYED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE NOT RETAINED, BUT ADDITIONAL DEVICES FROM THE SAME LOT WILL BE RETURNED FOR CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274265 MYNXGRIP VASCULAR CLOSURE DEVICE 5F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX5021 F2209401 10862028000403

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 5F TERUMO SHEATH