BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL

    MDR report key: 20265926 · Received September 20, 2024

    Report

    Report Number
    9616099-2024-00307
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 20, 2024
    Manufacturer
    CORDIS US CORP
    Product Code
    MGB
    UDI-DI
    10705032058865
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, WHILE USING A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD), THE DOCTOR DEPLOYED THE PLUG WHILE CHECKING IT UNDER FLUOROSCOPY, BUT IT SEEMED TO DEPLOY A LITTLE EARLIER THAN USUAL. WHEN CHECKING WITH AN ULTRASOUND WHILE APPLYING PRESSURE TO STOP THE BLEEDING, IT APPEARED THAT PART OF THE PLUG WAS PROTRUDING INTO THE BLOOD VESSEL. THE DOCTOR APPROACHED THE PLUG FROM THE OPPOSITE SIDE USING A 6F NON-CORDIS SHEATH AND PERFORMED ANGIOGRAPHY TO CONFIRM THAT PART OF THE PLUG WAS PROTRUDING INTO THE BLOOD VESSEL. AN ATTEMPT WAS MADE TO REMOVE IT. THE PLUG WAS GRASPED WITH A SNARE CATHETER, RETRIEVED INTO THE SHEATH, AND THEN REMOVED FROM THE BODY. WHEN THE PLUG WAS RETRIEVED, BLEEDING OCCURRED AT THE PUNCTURE SITE. MANUAL COMPRESSION WAS HELD FOR ABOUT TWENTY (20) MINUTES TO ACHIEVE HEMOSTASIS. THE ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE WAS COMPLETED USING AN IPSILATERAL ANTEGRADE APPROACH. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER, AND THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5MM. THERE WAS NO VISIBLE CALCIUM OR PLAQUE AT THE PUNCTURE SITE, NO ACCESS VESSEL TORTUOSITY, NO STENT NEAR THE PUNCTURE SITE, AND NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO EXOSEAL VCD USE. THE VESSEL DID NOT HAVE STENOSIS GREATER THAN FIFTY PERCENT (50%) AT OR NEAR THE PUNCTURE SITE. THE TARGET FEMORAL SITE HAD NOT BEEN PREVIOUSLY CLOSED WITH ANY CLOSURE DEVICE OR MANUAL COMPRESSION LESS THAN THIRTY (30) DAYS PRIOR TO THIS PROCEDURE. THE DEPLOYMENT BUTTON WAS FULLY DEPRESSED AND FLUSHED AGAINST THE HANDLE, AND THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER WERE REMOVED AS A SINGLE UNIT FROM THE PATIENT APPROXIMATELY 1-2 SECONDS AFTER DEPRESSING THE DEPLOYMENT BUTTON. THE WIRES WERE IN THE SYSTEM PROPERLY WHEN THE DEVICE WAS REMOVED. THERE WAS NO BLOOD FLOW OBSERVED FROM THE BLEED-BACK INDICATOR WHEN THE BUTTON WAS DEPRESSED. THE EXOSEAL VCD WAS CONSISTENTLY RETRACTED FROM THE PATIENT DURING USE. THE PATIENT SHOWED NO SIGNS AND SYMPTOMS OF DISTAL BLOOD FLOW OCCLUSION AND RECOVERED AFTER THE EVENT. PROCEDURAL FILMS WERE NOT AVAILABLE. THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD, HAVING USED IT OVER FIFTY (50) TIMES. THE DEVICE WILL NOT BE SHIPPED FOR ANALYSIS AS IT WAS DISCARDED. THE REPORTED EVENT OF ¿PLUG-INACCURATE PLACEMENT-INTRAVASCULAR¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND PROCEDURAL IMAGES WERE NOT PROVIDED. THE EXACT CAUSE OF THE ISSUE EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, PROCEDURAL/HANDLING FACTORS (DEVICE WAS USED ON AN ANTEGRADE APPROACH SITE) LIKELY CONTRIBUTED TO THE EVENT THAT OCCURRED SINCE THE INTRAVASCULAR DEPLOYMENT WAS NOTED RIGHT AFTER PLUG RELEASE. INTRAVASCULAR DEPLOYMENTS USUALLY REQUIRE ADDITIONAL INTERVENTION, SUCH AS THROMBECTOMY, STENTING, OR SURGICAL INTERVENTION IN ORDER TO RESTORE/IMPROVE FLOW. 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 WARNS, ¿THE EXOSEAL VASCULAR CLOSURE DEVICE PROCEDURE SHOULD BE PERFORMED BY PHYSICIANS WHO HAVE EXPERTISE IN THE TECHNIQUES OF VASCULAR CATHETERIZATION (OR OTHER HEALTHCARE PROFESSIONALS AUTHORIZED BY, OR UNDER THE DIRECTION OF, SUCH PHYSICIANS) AND POSSESS ADEQUATE TRAINING IN THE USE OF THE DEVICE, E.G., PARTICIPATION IN AN EXOSEAL CLOSURE DEVICE TRAINING PROGRAM.¿ THE IFU ALSO STATES THAT THE SAFETY AND EFFECTIVENESS OF THIS DEVICE IN AN ANTEGRADE APPROACH HAS NOT BEEN ESTABLISHED. AN ANTEGRADE APPROACH MAY NOT ALLOW FOR PROPER VISUALIZATION OF THE ACTUAL ARTERIOTOMY SITE, AS THE IMAGING DYE WILL FLOW AWAY FROM THE ACTUAL ARTERIOTOMY SITE WITH THIS APPROACH. ALSO, AN ANTEGRADE APPROACH COULD AFFECT THE PULSATILE FLOW SIGNAL FROM THE BLEED BACK INDICATOR OF THE EXOSEAL DEVICE. ACCORDING TO THE IFU, ¿OBSERVE PULSATILE FLOW FROM THE BLEED-BACK INDICATOR. USING THE LEFT HAND, SLOWLY RETRACT THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER AT THE ANGLE OF THE TISSUE TRACT (30-45 DEGREES) UNTIL PULSATILE FLOW HAS SIGNIFICANTLY SLOWED OR STOPPED FROM THE BLEED-BACK INDICATOR. WHILE HOLDING THE EXOSEAL VCD IN THE RIGHT HAND, MAKING SURE THE THUMB IS NOT PLACED ON THE PLUG DEPLOYMENT BUTTON, CONTINUE RETRACTING THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER VERY SLOWLY (CONTROLLING RETRACTION WITH THE LEFT HAND) UNTIL THE GRAPHIC PATTERN IN THE INDICATOR WINDOW CHANGES TO A SOLID BLACK COLOR, AT WHICH POINT THE PLUG IS CORRECTLY POSITIONED FOR DEPLOYMENT.¿ BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION THAT THE REPORTED EVENT IS 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, WHILE USING A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) THE DOCTOR DEPLOYED THE PLUG WHILE CHECKING IT UNDER FLUOROSCOPY, BUT IT SEEMED TO DEPLOY A LITTLE EARLIER THAN USUAL. WHEN CHECKING WITH AN ULTRASOUND WHILE APPLYING PRESSURE TO STOP THE BLEEDING, IT APPEARED THAT PART OF THE PLUG WAS PROTRUDING INTO THE BLOOD VESSEL. THE DOCTOR APPROACHED THE PLUG FROM THE OPPOSITE SIDE USING A 6F NON-CORDIS SHEATH AND PERFORMED ANGIOGRAPHY TO CONFIRM THAT PART OF THE PLUG WAS PROTRUDING INTO THE BLOOD VESSEL. AN ATTEMPT WAS MADE TO REMOVED IT. THE PLUG WAS GRASPED WITH A SNARE CATHETER, RETRIEVED INTO THE SHEATH AND THEN REMOVED FROM THE BODY. WHEN THE PLUG WAS RETRIEVED, BLEEDING OCCURRED AT THE PUNCTURE SITE. MANUAL COMPRESSION WAS HELD FOR ABOUT TWENTY (20) MINUTES TO ACHIEVE HEMOSTASIS. THE ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE WAS COMPLETED USING AN IPSILATERAL ANTEGRADE APPROACH. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER, AND THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5MM. THERE WAS NO VISIBLE CALCIUM OR PLAQUE AT THE PUNCTURE SITE, NO ACCESS VESSEL TORTUOSITY, NO STENT NEAR THE PUNCTURE SITE, AND NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO EXOSEAL VCD USE. THE VESSEL DID NOT HAVE STENOSIS GREATER THAN FIFTY PERCENT (50%) AT OR NEAR THE PUNCTURE SITE. THE TARGET FEMORAL SITE HAD NOT BEEN PREVIOUSLY CLOSED WITH ANY CLOSURE DEVICE OR MANUAL COMPRESSION LESS THAN THIRTY (30) DAYS PRIOR TO THIS PROCEDURE. THE DEPLOYMENT BUTTON WAS FULLY DEPRESSED AND FLUSHED AGAINST THE HANDLE, AND THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER WERE REMOVED AS A SINGLE UNIT FROM THE PATIENT APPROXIMATELY 1-2 SECONDS AFTER DEPRESSING THE DEPLOYMENT BUTTON. THE WIRES WERE IN THE SYSTEM PROPERLY WHEN THE DEVICE WAS REMOVED. THERE WAS NO BLOOD FLOW OBSERVED FROM THE BLEED-BACK INDICATOR WHEN THE BUTTON WAS DEPRESSED. THE EXOSEAL VCD WAS CONSISTENTLY RETRACTED FROM THE PATIENT DURING USE. THE PATIENT SHOWED NO SIGNS AND SYMPTOMS OF DISTAL BLOOD FLOW OCCLUSION AND RECOVERED AFTER THE EVENT. PROCEDURAL FILMS WERE NOT AVAILABLE. THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD, HAVING USED IT OVER FIFTY (50) TIMES. THE DEVICE WILL NOT BE SHIPPED FOR ANALYSIS AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329857 EXOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP 18300223 10705032058865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 6F DESTINATION| 6F TERUMO