BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    MDR report key: 6898425 · Received September 27, 2017

    Report

    Report Number
    3004939290-2017-00322
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    April 26, 2017
    Report Date
    September 27, 2017
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: 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. [email protected]. COMPLAINT CONCLUSION: IT WAS REPORTED THAT TWO 6F MYNX VASCULAR CLOSURE DEVICES (VCD) WAS USED WITH UNKNOWN 6F SHEATH THROUGH THE FEMORAL ARTERY. AFTER SHUTTLING DOWN THE ADVANCER TUBE, THE SEALANT LODGED IN CATHETER. 6CM OF HEMATOMA WAS NOTED. MANUAL COMPRESSION WAS HELD FOR 30 MINUTE OR LESS TO ACHIEVE HEMOSTASIS. INTERVENTIONAL PERIPHERAL WAS THE INTENDED PROCEDURE TYPE WITH A MEDIUM STICK LOCATION. 1451-1 THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT F1632402 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. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED EVENT 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. BASED ON THE DEVICE HISTORY RECORD REVIEW, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO 6F MYNX VASCULAR CLOSURE DEVICES (VCD) WAS USED WITH UNKNOWN 6F SHEATH THROUGH THE FEMORAL ARTERY. AFTER SHUTTLING DOWN THE ADVANCER TUBE, THE SEALANT LODGED IN CATHETER. 6CM OF HEMATOMA WAS NOTED. MANUAL COMPRESSION WAS HELD FOR 30 MINUTE OR LESS TO ACHIEVE HEMOSTASIS. THE PRODUCT IS BEING RETURNED FOR ANALYSIS. INTERVENTIONAL PERIPHERAL WAS THE INTENDED PROCEDURE TYPE WITH A MEDIUM STICK LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677607 MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX6721A F1632402

    Patients

    Seq Age Sex Outcome Treatment
    1