BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI AVANTI PLUS

    MDR report key: 2162134 · Received July 14, 2011

    Report

    Report Number
    9616099-2011-00481
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00480 AND 9616099-2011-00481.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00480 AND 9616099-2011-00481. INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT ONE HOUR AFTER THE EXOSEAL WAS IMPLANTED, THE PATIENT BEGAN TO BLEED. MANUAL COMPRESSION WAS REQUIRED TO ACHIEVE HEMOSTASIS AND THE PATIENT ALSO RECEIVED A BLOOD TRANSFUSION. THE PHYSICIAN HAD PERFORMED 10 PREVIOUS CASES. THE PATIENT'S LEVEL OF ANTICOAGULATION OR MEDICATIONS GIVEN WAS NOT PROVIDED. THE ARTERIOTOMY SUITABILITY WAS NOT VERIFIED UNDER ANGIOGRAPHY. A 6FR AVANTI SHEATH WAS USED; THE SHEATH LOCKED PROPERLY AGAINST THE COWLING AND AN AUDIBLE CLICK WAS HEARD WITH ADEQUATE BLEED/BACK BEING OBSERVED. PROPER INDICATION WAS OBSERVED IN THE INDICATOR WINDOW. THE PLUG DEPLOYMENT BUTTON WAS FULLY DEPRESSED AND THE PLUG DEPLOYED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE VASCULAR CLOSURE DEVICE (VCD). THE PROCEDURE WAS NOT ABORTED PRIOR TO PLUG DEPLOYMENT. THE VCD WAS REMOVED WITH THE SHEATH AS A SINGLE UNIT. THE PATIENT EXPERIENCED A BLEEDING COMPLICATION AND REQUIRED A BLOOD TRANSFUSION DUE TO RETROPERITONEAL HEMATOMA. THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. THERE WAS NO PRE-EXISTING HEMATOMA PRIOR TO INSERTION OF THE EXOSEAL VCD. THE LOT NUMBER FOR THE CORDIS SHEATH IS UNKNOWN. THE CURRENT STATUS OF THE PATIENT WAS OK AND WENT HOME. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE STERILE LOT NUMBER FOR (B)(4) IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONFIRMED. RETRO-PERITONEAL HEMATOMA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH GAINING ARTERIAL ACCESS. ACCESS SITE RELATED HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND MAY BE RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT; FROM THE AVAILABLE CLINICAL INFORMATION, IT COULD NOT BE DETERMINED IF ARTERIAL ACCESS WAS ACHIEVED WITH A SINGLE STICK OR IF MULTIPLE PUNCTURES WERE PRESENT. THERE IS ALSO NO INFORMATION REGARDING THE PATIENT'S COMFORT LEVEL OR MOBILITY AT THE TIME OF THE EVENT. WITH THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE EVENT BUT THERE ARE MULTIPLE FACTORS, SUCH AS COMFORT LEVEL, FULLNESS OF THE BLADDER AND ANTICOAGULATION FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INFORMATION DOES NOT SUGGEST A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE EVENT; NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AFTER ONE HOUR THE EXOSEAL WAS IMPLANTED, THE PATIENT BEGUN TO BLEED. THE PHYSICIAN HAD TO MAKE HAND COMPRESSION. THE PATIENT REQUIRED A BLOOD TRANSFUSION DUE TO RETROPERITONEAL HEMATOMA. A 6FR AVANTI SHEATH WAS USED. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING. AN AUDIBLE "CLICK" WAS HEARD AND AN ADEQUATE BLEED-BACK SIGNAL WAS OBSERVED. PROPER INDICATION WAS NOT OBSERVED IN THE INDICATOR WINDOW. THE PLUG DEPLOYMENT BUTTON WAS FULLY DEPRESSED AND THE PLUG DEPLOYED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE VASCULAR CLOSURE DEVICE (VCD). THE PROCEDURE WAS NOT ABORTED PRIOR TO PLUG DEPLOYMENT. THE VCD WAS REMOVED WITH THE SHEATH AS A SINGLE UNIT. THE PATIENT EXPERIENCED A BLEEDING COMPLICATION AND REQUIRED A BLOOD TRANSFUSION DUE TO RETROPERITONEAL HEMATOMA. THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. FEMORAL ARTERY SUITABILITY WAS NOT VERIFIED ON ANGIOGRAPHY. THERE WAS NO PRE-EXISTING HEMATOMA PRIOR TO INSERTION OF THE EXOSEAL VCD. THE LOT NUMBER FOR THE CORDIS SHEATH WAS UNKNOWN. THE CURRENT STATUS OF THE PATIENT WAS OK AND WENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI AVANTI PLUS CARDIOLOGY VASCULAR ACCESS (DRE) DRE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 6 FR AVANTI SHEATH