BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    MDR report key: 6906830 · Received October 2, 2017

    Report

    Report Number
    3004939290-2017-00372
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    May 31, 2017
    Report Date
    September 29, 2017
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INTEGRATION OF ACCESSCLOSURE, INC. INTO THE CORDIS BUSINESS MODEL, THE DETERMINATION WAS MADE THAT REPORTABILITY FOR PRODUCT FAILURE MODES WOULD BE ALIGNED WITH CURRENT REPORTABILITY FOR CORDIS PRODUCTS. THIS DECISION TO ALIGN REPORTABILITY WAS MADE, AS THE SAID FAILURE MODES, WOULD NOT RESULT IN PATIENT INJURY. AS A RESULT, THIS EVENT IS BEING FILED BEYOND THE 30-DAY FDA REQUIREMENT. (B)(4). COMPLAINT CONCLUSION: IT IS REPORTED THAT THE 6/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) SHEATH AND THE SEALANT WERE EXPOSED AFTER THE SHEATH RETRACTION. THE ADVANCER TUBE WAS NOT VISIBLE AND STUCK IN THE DEVICE. A 6F CORDIS SHEATH WAS USED. HEMATOMA (3-4MM) WAS NOTED. THE PRODUCT IS AVAILABLE FOR RETURN. MANUAL COMPRESSION WAS APPLIED FOR 20 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO DAMAGES OR ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THE DEVICE DID PREP NORMALLY. THE USER DID SHUTTLE DOWN COMPLETELY. THERE WAS NO SIGNIFICANT RESISTANCE WHEN SHUTTLING DOWN. THERE WAS UNUSUAL FORCE WHEN RETRACTING THE SHEATH. THE PATIENT'S HOSPITALIZATION WAS NOT EXTENDED. THE DEPLOYER WAS IN TRAINING IN THE MYNX DEVICES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT F1702603 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED EVENT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. BASED ON LIMITED INFORMATION AVAILABLE FOR REVIEW, CONTRIBUTING FACTORS TO THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, PROCEDURAL FACTORS ARE LIKELY. AS PER THE INSTRUCTIONS FOR USE, ¿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.¿ THE DHR REVIEW DOES NOT SUGGEST THAT THE FAILURE EXPERIENCED BY THE CUSTOMER IS RELATED TO THE MYNX MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THE REPORTED EVENT ¿HEMATOMA¿ COULD NOT BE CONFIRMED. PER THE INSTRUCTIONS FOR USE ¿HEMATOMA¿ IS A POTENTIAL ADVERSE EVENT WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE ENDOVASCULAR CLOSURE DEVICE. THE DHR REVIEW DOES NOT SUGGEST THAT THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE 6/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) SHEATH AND THE SEALANT WERE EXPOSED AFTER THE SHEATH RETRACTION. THE ADVANCER TUBE WAS NOT VISIBLE AND STUCK IN THE DEVICE. A 6F CORDIS SHEATH WAS USED. HEMATOMA (3-4MM) WAS NOTED. THE PRODUCT IS AVAILABLE FOR RETURN. MANUAL COMPRESSION WAS APPLIED FOR 20 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO DAMAGES OR ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THE DEVICE DID PREP NORMALLY. THE USER DID SHUTTLE DOWN COMPLETELY. THERE WAS NO SIGNIFICANT RESISTANCE WHEN SHUTTLING DOWN. THERE WAS UNUSUAL FORCE WHEN RETRACTING THE SHEATH. THE PATIENT'S HOSPITALIZATION WAS NOT EXTENDED. THE DEPLOYER WAS IN TRAINING IN THE MYNX DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686433 MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX6721 F1702603

    Patients

    Seq Age Sex Outcome Treatment
    1