BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 8631978 · Received May 22, 2019

    Report

    Report Number
    3004939290-2019-01206
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 22, 2019
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    UDI-DI
    10862028000403
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THREE 5F MYNXGRIP VASCULAR CLOSURE DEVICES FAILED TO DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY. THE USER SHUTTLED DOWN COMPLETELY. THERE WAS NO SIGNIFICANT RESISTANCE WHEN SHUTTLING DOWN. THERE WAS NO UNUSUAL FORCE APPLIED WHEN RETRACTING THE SHEATH. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORD (PHR) REVIEWS OF LOT F1907401 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINTS. THE REPORTED ¿SEALANT FAILURE TO DEPLOY¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE FAILURE TO DEPLOY EVENTS REPORTED COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. HOWEVER, HANDLING FACTORS ARE POSSIBLE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, ¿WHILE PULLING LIGHTLY ON THE DEVICE HANDLE (TO ENSURE THE BALLOON IS ABUTTING THE ARTERIOTOMY OR VENOTOMY), OPEN THE PROCEDURAL SHEATH STOPCOCK AND CONFIRM TEMPORARY HEMOSTASIS. DETACH SHUTTLE AND ADVANCE IN A CONTINUOUS MOTION UNTIL A DEFINITIVE STOP IS FELT. IMMEDIATELY GRASP THE PROCEDURAL SHEATH AND WITHDRAW IT FROM THE TISSUE TRACT. CONTINUE RETRACTING UNTIL THE SHUTTLE LOCKS ON THE HANDLE.¿ IT SHOULD BE NOTED THAT IF THE SHUTTLE IS NOT ADVANCED UNTIL THE ADVANCER TUBE IS ENGAGED TO THE PROXIMAL TAMP LOCK, THIS WILL CAUSE THE ADVANCER TUBE AND SEALANT TO FOLLOW THE SHUTTLE CARTRIDGE BACK OUT OF THE TISSUE TRACT DURING THE RETRACTION STEP, RESULTING IN THE DEVICE FAILING TO DEPLOY. BASED ON THE PRODUCT HISTORY RECORD REVIEWS AND THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE 5F MYNXGRIP VASCULAR CLOSURE DEVICES FAILED TO DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY. THE USER SHUTTLED DOWN COMPLETELY. THERE WAS NO SIGNIFICANT RESISTANCE WHEN SHUTTLING DOWN. THERE WAS NO UNUSUAL FORCE APPLIED WHEN RETRACTING THE SHEATH. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427785 MYNXGRIP VASCULAR CLOSURE DEVICE 5F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX5021 F1907401 10862028000403

    Patients

    Seq Age Sex Outcome Treatment
    1