BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    MDR report key: 11344867 · Received February 18, 2021

    Report

    Report Number
    3004939290-2021-02072
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 27, 2021
    Report Date
    March 5, 2021
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    UDI-DI
    10862028000410
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE PROCEDURE, THE BALLOON OF A 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS NOT ANCHORED INSIDE THE VESSEL PROPERLY. IT WAS RETRACTED WHEN THE USER WITHDREW THE UNKNOWN BALLOON CATHETER UNTIL THE BALLOON ABUTTED THE DISTAL TIP OF THE UNKNOWN PROCEDURAL SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING. THERE WAS NO SCAR TISSUE PRESENT IN THE VICINITY OF THE PUNCTURE SITE. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS MILD TORTUOSITY. THE MYNX VCD¿S WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) INSTRUCTIONS. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. NO OTHER INFORMATION WAS PROVIDED. THE PRODUCT WAS RETURNED FOR ANALYSIS. A NON-STERILE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED FOR INVESTIGATION. PER VISUAL ANALYSIS, THE SHUTTLE WAS DISENGAGED FROM THE BLACK HANDLE WITH THE STOPCOCK OPEN. THE SEALANT AND ADVANCER TUBE WERE OBSERVED TO HAVE REMAINED IN THE OUTER CARTRIDGE TUBING AS RECEIVED. THE SYRINGE AND PROCEDURAL SHEATH WERE NOT RETURNED WITH THE DEVICE. DRIED CONTRAST SOLUTION RESIDUAL WAS OBSERVED IN THE BALLOON OF THE RETURNED DEVICE. PER FUNCTIONAL ANALYSIS, THE BALLOON OF THE RETURNED DEVICE COULD NOT BE INFLATED AS THE CATHETER LUMEN WAS CLOGGED WITH DRIED CONTRAST SOLUTION. THE DEVICE WAS SUBMERGED IN A LAB ULTRASOUND BATH TO CLEAR THE BLOCKAGE WITHOUT SUCCESS. THEN THE CATHETER TUBING WAS CUT AND CONNECTED TO A PRESSURE GAUGE VIA 3-WAY STOPCOCK TO INFLATE THE BALLOON WITHOUT SUCCESS. ALL THE ATTEMPTS TO INFLATE THE BALLOON WERE EXHAUSTED. PER MICROSCOPIC ANALYSIS, EVIDENCE OF DRIED DILUTED CONTRAST SOLUTION IN THE BALLOON AND THE BALLOON DISTAL TIP WAS SEVERELY INVERTED WERE OBSERVED. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F1921703 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿BALLOON PULL THROUGH¿ WAS NOT CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. DUE TO THE CONDITION OF THE RETURNED DEVICE, A COMPLETE PHYSICAL EVALUATION COULD NOT BE PERFORMED. MULTIPLE ATTEMPTS WERE MADE TO CLEAR THE CLOGGED CONTRAST SOLUTION FROM THE CATHETER TUBING AND TO INFLATE THE BALLOON. THE INVERTED BALLOON TIP INDICATE THAT EXCESSIVE TENSION MAY HAVE BEEN APPLIED ON THE DEVICE DURING PULLBACK WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿REMOVE DEVICE¿, IT INSTRUCTS USERS TO ENSURE COMPLETE BALLOON DEFLATION, THEN SLOWLY WITHDRAW THE BALLOON CATHETER THROUGH THE ADVANCER TUBE LUMEN. FAILURE TO HOLD THE ADVANCER TUBE IN PLACE AND/OR A PROPER POSITION OF THE TAMPING TUBE NOT BEING MAINTAINED DURING CATHETER REMOVAL, COULD DISLODGE THE SEALANT FROM THE VESSEL WALL. NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    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 THE PROCEDURE, THE BALLOON OF A 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS NOT ANCHORED INSIDE THE VESSEL PROPERLY. IT WAS RETRACTED WHEN THE USER WITHDREW THE UNKNOWN BALLOON CATHETER UNTIL THE BALLOON ABUTTED THE DISTAL TIP OF THE UNKNOWN PROCEDURAL SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGED TO THE DEVICES¿ PACKAGING. THERE WAS NO SCAR TISSUE PRESENT IN THE VICINITY OF THE PUNCTURE SITE. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE IS MILD TORTUOSITY. THE MYNX VCD¿S WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) INSTRUCTIONS. FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238878 MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX6721 F1921703 10862028000410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BALLOON CATHETER| UNK SHEATH