BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    MDR report key: 8555210 · Received April 26, 2019

    Report

    Report Number
    3004939290-2019-01174
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 8, 2019
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    UDI-DI
    10862028000410
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING USE OF THE MYNXGRIP VASCULAR CLOSURE DEVICE, THE SEALANT WOULD NOT DEPLOY. THERE WAS NO PATIENT INJURY. MANUAL PRESSURE WAS HELD FOR FIFTEEN MIN THEN THE STICK WAS DRESSED WITH GAUZE AND TEGADERM. THE MYNXGRIP WAS USED TO CLOSE THE LEFT COMMON FEMORAL, AFTER A ROUTINE LOWER EXTREMITY ANGIOGRAM. THE PHYSICIAN SHUTTLED DOWN AND PULLED THE SHEATH UP BUT THERE WAS NO SEALANT OR ADVANCER TUBE; IT WAS STILL INSIDE THE DOCK. FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, 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 (VESSEL SIZE IS 6 MM). THE ACCESS POINT WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH NO PRESENCE OF PVD, CALCIUM, OR SCAR TISSUE IN THE VICINITY OF THE PUNCTURE SITE. THE PATIENT WAS NOT HOSPITALIZED. THE MYNX VCD WAS PREP ACCORDING TO THE INSTRUCTION FOR USE (IFU). AN ANTEGRADE APPROACH WAS USED. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F1834602 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 - ADVANCER TUBE¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE FAILURE TO DEPLOY EVENT 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 ISSUES. HOWEVER, IT COULD BE RELATED TO PROCEDURAL/HANDLING FACTORS, SUCH AS INCOMPLETE SHUTTLING DOWN OF THE SHUTTLE. 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. NEITHER THE PHR REVIEW NOR THE INFORMATION PROVIDED SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BOSTON SCIENTIFIC V-18 CONTROL GLIDE WIRE, COOK CXI SUPPORT CATHETER, CSI VIPER WIRE ADVANCE, VOLCANO PHOENIX ATHERECTOMY CATHETER, BARD PERIPHERAL VASCULAR, INC. PRESTO INFLATION DEVICE, BOSTON SCIENTIFIC COYOTE, 3.0MM X 100MM X 90CM, OTW BALLOON. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING USE OF THE MYNXGRIP VASCULAR CLOSURE DEVICE, THE SEALANT WOULD NOT DEPLOY. THERE WAS NO PATIENT INJURY. MANUAL PRESSURE WAS HELD FOR FIFTEEN MIN THEN THE STICK WAS DRESSED WITH GAUZE AND TEGADERM. THE MYNXGRIP WAS USED TO CLOSE THE LEFT COMMON FEMORAL, AFTER A ROUTINE LOWER EXTREMITY ANGIOGRAM. THE PHYSICIAN SHUTTLED DOWN AND PULLED THE SHEATH UP BUT THERE WAS NO SEALANT OR ADVANCER TUBE; IT WAS STILL INSIDE THE DOCK. FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, 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 (VESSEL SIZE IS 6 MM). THE ACCESS POINT WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH NO PRESENCE OF PVD, CALCIUM, OR SCAR TISSUE IN THE VICINITY OF THE PUNCTURE SITE. THE PATIENT WAS NOT HOSPITALIZED. THE MYNX VCD WAS PREP ACCORDING TO THE INSTRUCTION FOR USE (IFU). AN ANTEGRADE APPROACH WAS USED. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349717 MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX6721 F1834602 10862028000410

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR