BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL

    MDR report key: 20062578 · Received August 26, 2024

    Report

    Report Number
    9616099-2024-00280
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 12, 2024
    Manufacturer
    CORDIS US CORP
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE REMAINS UNKNOWN. THIS DEVICE IS REPORTED TO BE AVAILABLE FOR ANALYSIS BUT HAS NOT BEEN DOCUMENTED AS RECEIVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B3, B5, D4, D9, G3, G6, H2, H3, H6, AND H11. THE DEVICE CATALOG AND LOT INFORMATION WILL REMAIN UNKNOWN. COMPLAINT CONCLUSION: AS REPORTED, THE INDICATOR WINDOW OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) DOES NOT CLOSE; IT DID NOT CHANGE TO BLACK. THE INDICATOR WIRE IS "HARDENED" AND ONLY LOOSENS OUTSIDE THE SKIN. THEN, THE WINDOW CLOSES. SECONDARY HEMORRHAGE HAD TO BE TREATED SURGICALLY AS A RESULT. SURGICAL INTERVENTION WAS REQUIRED ON THE SAME DAY OF THE PROCEDURE WITH SURGICAL RESECTION OF A GROIN HEMATOMA AND SUTURE OF ARTERY. A NON-CORDIS "LOCK" WAS USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE REPORTED EVENT OF ¿INDICATOR WINDOW-NO CHANGE TO INDICATOR¿ AND THE REPORTED ¿HEMORRHAGE¿ AND ¿HEMATOMA¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND PROCEDURAL IMAGES WERE NOT PROVIDED. THE EXACT CAUSE OF THE ISSUES EXPERIENCED 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 NO CHANGE TO THE INDICATOR. HOWEVER, HANDLING FACTORS ARE POSSIBLE. ACCESS SITE HEMATOMAS/HEMORRHAGES ARE A COMMON POST-PROCEDURAL COMPLICATION AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. ACCESS SITE HEMORRHAGE EVENTS AFTER MANUAL COMPRESSION ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE, ADEQUATE MANUAL COMPRESSION TECHNIQUE, AND THE PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF THE AFFECTED LIMB IN ORDER TO PROMOTE COAGULATION. ACCESS SITE BLEEDING EVENTS CAN REQUIRE PROLONGED MANUAL COMPRESSION, BLOOD TRANSFUSION, OR EVEN SURGICAL INTERVENTION. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS OR PROCEDURAL FILMS, NO DETERMINATION OF POSSIBLE PRODUCT CONTRIBUTING FACTORS COULD BE MADE. ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, THE INFORMATION FOR SAFETY WITHIN THE IFU IS PROVIDED IN THE PRODUCT¿S LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. THE IFU STATES, DURING RETRACTION OF THE EXOSEAL DEVICE AND THE SHEATH AS A SINGLE UNIT, IT IS IMPORTANT TO ENSURE THAT THE OPERATOR¿S THUMB IS NOT PLACED OR RESTING ON THE PLUG DEPLOYMENT BUTTON (PER PROCEDURE STEP 7 IN THE EXOSEAL INSTRUCTIONS FOR USE). THE IFU PROVIDES THE FOLLOWING CAUTION: (XI.7), ¿IF THE GRAPHIC PATTERN IN THE INDICATOR WINDOW DOES NOT CHANGE TO A SOLID BLACK COLOR AFTER APPROXIMATELY 1CM OF RETRACTION FROM THE POINT THAT PULSATILE FLOW SIGNIFICANTLY SLOWED OR HAS STOPPED, DISCONTINUE THE USE OF THE DEVICE.¿ THE PRECAUTIONS SECTION IN THE IFU INDICATES THAT SERIOUS ADVERSE EVENTS MIGHT RESULT WITH THE USE OF THE EXOSEAL VCD IN VESSELS NOT SUITABLE FOR THE USE OF THE DEVICE. ADDITIONALLY STATED IN THE IFU, ¿IF HEMOSTASIS HAS NOT OCCURRED, CONTINUE APPLYING LIGHT MANUAL PRESSURE TO ACHIEVE HEMOSTASIS.¿ BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION THAT THE REPORTED EVENTS COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, THE CONTROL WINDOW OF A 5F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) DOES NOT CLOSE. THE "CURL IS HARDENED" AND ONLY LOOSENS OUTSIDE THE SKIN. THEN, THE WINDOW CLOSES. SECONDARY HEMORRHAGE HAD TO BE TREATED SURGICALLY AS A RESULT. A NON-CORDIS "LOCK" WAS USED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, THE INDICATOR WINDOW OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) DOES NOT CLOSE; IT DID NOT CHANGE TO BLACK. THE INDICATOR WIRE IS "HARDENED" AND ONLY LOOSENS OUTSIDE THE SKIN. THEN, THE WINDOW CLOSES. SECONDARY HEMORRHAGE HAD TO BE TREATED SURGICALLY AS A RESULT. SURGICAL INTERVENTION WAS REQUIRED ON THE SAME DAY OF THE PROCEDURE WITH SURGICAL RESECTION OF A GROIN HEMATOMA AND SUTURE OF ARTERY. A NON CORDIS "LOCK" WAS USED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160066 EXOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TERUMO "LOCK".