BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2982752 · Received February 28, 2013

    Report

    Report Number
    3004939290-2013-00057
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE WAS DISENGAGED FROM THE HANDLE. THE SEALANT WAS FLUSH WITH THE DISTAL END OF THE SHUTTLE CARTRIDGE. THE SEALANT GRIP TIP WAS STUCK TO THE CATHETER SHAFT AND THE SHUTTLE CARTRIDGE. THE ADVANCER TUBE WAS FOUND INSIDE THE SHUTTLE CARTRIDGE. THIS RECEIVED CONDITION INDICATES AN INCOMPLETE ENGAGEMENT OF THE ADVANCER TUBE. THE SHUTTLE DOWN PROCEDURE WAS SIMULATED AND THE ADVANCER TUBE WAS ABLE TO PROPERLY ENGAGE THE TAMP LOCKS. THE CATHETER, SHUTTLE CARTRIDGE AND INTRODUCER SHEATH WERE INSPECTED FOR ANOMALIES THAT MAY HAVE OBSTRUCTED THE DEVICE PATH DURING DEPLOYMENT. NO ANOMALIES WERE OBSERVED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE REPORTED FAILURE TO DEPLOY COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1234101) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INFORMATION IS BEING CORRECTED. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE WAS DISENGAGED FROM THE HANDLE. THE SEALANT WAS FLUSH WITH THE DISTAL END OF THE SHUTTLE CARTRIDGE. THE SEALANT GRIP TIP WAS STUCK TO THE CATHETER SHAFT AND THE SHUTTLE CARTRIDGE. THE ADVANCER TUBE WAS FOUND INSIDE THE SHUTTLE CARTRIDGE. THIS RECEIVED CONDITION INDICATES AN INCOMPLETE ENGAGEMENT OF THE ADVANCER TUBE. THE SHUTTLE DOWN PROCEDURE WAS SIMULATED AND THE ADVANCER TUBE WAS ABLE TO PROPERLY ENGAGE THE TAMP LOCKS. THE CATHETER, SHUTTLE CARTRIDGE AND INTRODUCER SHEATH WERE INSPECTED FOR ANOMALIES THAT MAY HAVE OBSTRUCTED THE DEVICE PATH DURING DEPLOYMENT. DAMAGE WAS OBSERVED AT THE DISTAL TIP OF THE INTRODUCER SHEATH . BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE REPORTED FAILURE TO DEPLOY COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1234101) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI CLINICAL SPECIALIST THAT A (B)(6) MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE MID COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM AT THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE "SEALANT DID NOT DEPLOY AFTER THE PHYSICIAN SHUTTLED DOWN". THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED. MANUAL COMPRESSION WAS APPLIED AT THE ACCESS SITE FOR 5 MINUTES IN THE PROCEDURE ROOM IN CONJUNCTION WITH A D STAT PATCH. A CLAMP WAS PLACED ON THE ACCESS SITE IN THE RECOVERY ROOM FOR 90 MINUTES. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86603 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1234101

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ANGIOMAX