BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL

    MDR report key: 21055638 · Received January 2, 2025

    Report

    Report Number
    9616099-2025-00006
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 31, 2025
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MGB
    UDI-DI
    10705032058896
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, THE INDICATOR WINDOW OF A 7F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) DID NOT CHANGE THE COLOR DURING USE. FINALLY, SURGEON WITHDREW THE DEVICE AND CHANGED TO MANUAL COMPRESSION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO DIFFICULTY CONNECTING THE 7F NON-CORDIS VASCULAR SHEATH INTRODUCER WITH THE EXOSEAL VCD. THE INDICATOR WIRE COWLING LOCKED AGAINST THE HANDLE ASSEMBLY AND AN AUDIBLE CLICK WAS HEARD. THERE WAS PULSATILE FLOW OBSERVED FROM THE BLEED-BACK INDICATOR. THE EXOSEAL VCD AND 7F NON-CORDIS VASCULAR SHEATH INTRODUCER WERE RETRACTED TOGETHER UNTIL BLEED BACK SIGNIFICANTLY SLOWED OR STOPPED. THE PHYSICIAN DID NOT HAVE THEIR THUMB PLACED ON THE PLUG DEPLOYMENT BUTTON DURING RETRACTION. THE INDICATOR WINDOW DID NOT SHOW ANY RED COLOR DURING RETRACTION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE INDICATOR WIRE LOOP WAS DEPLOYED/SHOWING. THE GUIDEWIRE LOOP COULD NOT BE PULLED OUTSIDE THE PATIENT. A 7F NON-CORDIS SHEATH WAS USED. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE 7F NON-CORDIS VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5MM IN DIAMETER. THE PUNCTURE SITE DID NOT HAVE VISIBLE CALCIUM/PLAQUE. THERE WAS NO ACCESS VESSEL TORTUOSITY. THERE WAS NO STENT NEAR THE PUNCTURE SITE. THE VESSEL DID NOT HAVE STENOSIS >50% AT OR NEAR THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE DEVICE OR MANUAL COMPRESSION LESS THAN THIRTY DAYS PRIOR TO THIS PROCEDURE. THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO EXOSEAL VCD USE. THE EXOSEAL VCD WAS USED IN AN INTERVENTIONAL PROCEDURE WITH A RETROGRADE APPROACH. THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD. THE PATIENT¿S BODY MASS INDEX (BMI) WAS NOT GREATER THAN 40. THE PATIENT DOES NOT HAVE A HISTORY OF INFECTIOUS DISEASES. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. ONE NON-STERILE VASCULAR CLOSURE DEVICE 7F - US WAS RECEIVED FOR ANALYSIS INSIDE A PLASTIC BAG. THE DEVICE WAS UNPACKED TO PROCEED WITH THE ANALYSIS. PER VISUAL ANALYSIS, THE UNIT WAS ALREADY INSERTED INTO A NON-CORDIS CSI, THE DEPLOYMENT LEVER ON THE DEVICE WAS NOT PRESSED AND THE PLUG WAS PRESENT ON THE DELIVERY SHAFT, WHICH WAS FOUND WITH DRIED BLOOD RESIDUES, WITH THE INDICATOR WIRE DEPLOYED AND THE LOOP IN GOOD CONDITIONS. THE INDICATOR WINDOW WAS RECEIVED ON WHITE/BLACK POSITION AND THE COWLING GUARD WAS FOUND LOCKED. NO ANOMALIES WERE OBSERVED DURING THE ANALYSIS. IN ACCORDANCE WITH PROCEDURE, IT WAS CONFIRMED THAT THE PLUG WAS NOT DEPLOYED, AND THE GUARD WAS LOCKED WITH THE INDICATOR WIRE (IW) DEPLOYED. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE BLOOD RESIDUES CLOGGED DEVICE. ATTEMPTS TO CLEAN THE DEVICE USING HYDROGEN PEROXIDE IN AN ULTRASONIC BATH WERE PERFORMED, WITH NO SUCCESS. THE PINION GEAR-IW RACK TIMING WAS REVIEWED, THE IW END INTERACTION WITH THE IW RACK PILLARS WAS EXAMINED FOR POTENTIAL INTERFERENCE, AND THE IW WAS INSPECTED FOR BUCKLING. NO ANOMALIES WERE FOUND ON THE INTERNAL MECHANISM OF THE UNIT. THE INDICATOR WINDOW WAS MANUALLY MOVED AND SUCCESSFULLY TRANSITIONED THE THREE STAGES. MICROSCOPICAL ANALYSIS WAS NOT NEEDED SINCE THE INTERNAL MECHANISM WAS REVIEWED IN FUNCTIONAL ANALYSIS. THE REPORTED EVENT OF ¿INDICATOR WINDOW-NO CHANGE TO INDICATOR¿ WAS NOT CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE AS IT PASSED FUNCTIONAL ANALYSIS BY ACHIEVING ALL THREE STAGES OF THE INDICATOR WINDOW AND THERE WERE NO ANOMALIES NOTED TO THE INTERNAL MECHANISM. THE EXACT CAUSE OF THE ISSUE EXPERIENCED COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND PRODUCT ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED NO CHANGE TO INDICATOR EVENT AS THE FUNCTIONAL TEST COULD NOT BE FULLY PERFORMED DUE TO THE RECEIVED CONDITION WITH THE DRIED BLOOD THAT COULD NOT BE CLEANED OUT IN ORDER TO MOVE THE MECHANISM APPROPRIATELY. HOWEVER, AS THIS CONDITION WOULD NOT HAVE BEEN EXPERIENCED BY THE USER, TESTING OF THE INDICATOR WINDOW WITHIN THE HANDLE WAS PERFORMED AND IT WAS ABLE TO ACHIEVE ALL 3 STAGES OF THE INDICATOR WINDOW DURING FUNCTIONAL ANALYSIS. THEREFORE, IT IS POSSIBLE THAT PROCEDURAL/HANDLING FACTORS (SUCH AS THE PHYSICIAN RESTING A THUMB ON THE DEPLOYMENT LEVER DURING THE RETRACTION STEP) CONTRIBUTED TO THE ISSUE EXPERIENCED DURING THE PROCEDURE. AS CAUTIONED IN THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, ¿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.¿ ADDITIONALLY, THE IFU INSTRUCTS, ¿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. CAUTION: PULSATILE FLOW IS NECESSARY FOR PROPER EXOSEAL¿ VCD POSITIONING. IF PULSATILE FLOW IS NOT OBSERVED FROM THE BLEED-BACK INDICATOR, DISCONTINUE THE PROCEDURE. 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. CAUTION: IF THE GRAPHIC PATTERN IN THE INDICATOR WINDOW DOES NOT CHANGE TO A SOLID BLACK COLOR AFTER APPROXIMATELY 1 CM OF RETRACTION FROM THE POINT PULSATILE FLOW SIGNIFICANTLY SLOWED OR STOPPED, DISCONTINUE THE USE OF THE DEVICE.¿ NEITHER THE PRODUCT ANALYSIS, NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGEST THAT THE REPORTED FAILURE 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 INDICATOR WINDOW OF A 7F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) DID NOT CHANGE THE COLOR DURING USE. FINALLY, SURGEON WITHDREW THE DEVICE AND CHANGED TO MANUAL COMPRESSION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO DIFFICULTY CONNECTING THE 7F NON-CORDIS VASCULAR SHEATH INTRODUCER WITH THE EXOSEAL VCD. THE INDICATOR WIRE COWLING LOCKED AGAINST THE HANDLE ASSEMBLY AND AN AUDIBLE CLICK WAS HEARD. THERE WAS PULSATILE FLOW OBSERVED FROM THE BLEED-BACK INDICATOR. THE EXOSEAL VCD AND 7F NON-CORDIS VASCULAR SHEATH INTRODUCER WERE RETRACTED TOGETHER UNTIL BLEED BACK SIGNIFICANTLY SLOWED OR STOPPED. THE PHYSICIAN DID NOT HAVE THEIR THUMB PLACED ON THE PLUG DEPLOYMENT BUTTON DURING RETRACTION. THE INDICATOR WINDOW DID NOT SHOW ANY RED COLOR DURING RETRACTION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE INDICATOR WIRE LOOP WAS DEPLOYED/SHOWING. THE GUIDEWIRE LOOP COULD NOT BE PULLED OUTSIDE THE PATIENT. A 7F NON-CORDIS SHEATH WAS USED. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE 7F NON-CORDIS VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5MM IN DIAMETER. THE PUNCTURE SITE DID NOT HAVE VISIBLE CALCIUM/PLAQUE. THERE WAS NO ACCESS VESSEL TORTUOSITY. THERE WAS NO STENT NEAR THE PUNCTURE SITE. THE VESSEL DID NOT HAVE STENOSIS >50% AT OR NEAR THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE DEVICE OR MANUAL COMPRESSION LESS THAN THIRTY DAYS PRIOR TO THIS PROCEDURE. THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO EXOSEAL VCD USE. THE EXOSEAL VCD WAS USED IN AN INTERVENTIONAL PROCEDURE WITH A RETROGRADE APPROACH. THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD. THE PATIENT¿S BODY MASS INDEX (BMI) WAS NOT GREATER THAN 40. THE PATIENT DOES NOT HAVE A HISTORY OF INFECTIOUS DISEASES. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167616 EXOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS CORPORATION 18362593 10705032058896

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female 7F TERUMO SHORT SHEATH