BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3182898 · Received June 21, 2013

    Report

    Report Number
    9616099-2013-00391
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUED: THE BLEED-BACK INDICATOR WAS NOT VISIBLY DAMAGED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN NOTED, THE PATIENT WAS ON DIALYSIS WHICH IT WAS CONSIDERED THAT THE ACCESS SITE MIGHT BE CALCIFIED. THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD. IT IS UNKNOWN THE AMOUNT OF TIMES HE HAS USED THE DEVICE PRIOR TO THIS PROCEDURE. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING THE USE OF AN EXOSEAL VASCULAR CLOSURE DEVICE, IT WAS REPORTED THAT, ALTHOUGH THE INDICATOR WINDOW CHANGED TO BLACK-BLACK PATTERN, THE PULSATILE FLOW FROM BLEED BACK INDICATOR WOULD NOT SIGNIFICANTLY SLOW. THEREFORE, THE EXOSEAL WITH THE SHEATH INTRODUCER WAS REMOVED FROM THE PATIENT WITHOUT PLUG PLACEMENT AND HOMEOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. NO BLEEDING COMPLICATIONS OCCURRED DURING AND AFTER THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5MM IN DIAMETER. THERE WAS NO STENT NEAR THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE DEVICE OR MANUAL COMPRESSION LESS THAN 30 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. THERE WAS MODERATE CALCIFICATION WITH NO STENOSIS OBSERVED AT THE APPROACH SITE. THE EXOSEAL VCD WAS PREPPED ACCORDING TO IFU INSTRUCTIONS AND THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE FEMORAL ARTERY WAS ACCESSED WITH A 4.5F PARENT SHEATH INTRODUCER. AN ANTEGRADE APPROACH WAS USED. AFTER THE PTA, THE SHEATH INTRODUCER WAS EXCHANGED FOR A 6F BRITE TIP AND THE EXOSEAL WERE INSERTED INTO THE SHEATH INTRODUCER WITH NO DIFFICULTY. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED AS THE EXOSEAL VCD WAS ADVANCED THROUGH THE SHEATH. THE EXOSEAL VCD SECURELY LOCKED WITH THE VASCULAR SHEATH INTRODUCER. THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER RETRACTED TOGETHER UNTIL THE INDICATOR WINDOW CHANGED TO SOLID BLACK COLOR. HOWEVER, THE PULSATILE FLOW FROM BLEED BACK INDICATOR WOULD NOT SIGNIFICANTLY SLOW. THE BLEED-BACK INDICATOR WAS NOT VISIBLY DAMAGED. THE PHYSICIAN NOTED, THE PATIENT WAS ON DIALYSIS WHICH IT WAS CONSIDERED THAT THE ACCESS SITE MIGHT BE CALCIFIED. THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. ONE NON-STERILE 6F EXOSEAL WAS RECEIVED INSIDE A PLASTIC BAG. THE UNIT WAS INSERTED TO A 6F CORDIS SHEATH INTRODUCER. INDICATOR WINDOW WAS RECEIVED ON BLACK/ WHITE POSITION. THE GUARD WAS DEPRESSED, INDICATOR WIRE WAS DEPLOYED, AND DEPLOYMENT LEVER WAS NOT DEPRESSED. PLUG WAS ATTACHED TO THE DELIVERY SHAFT. BLOOD RESIDUES WERE NOTED IN THE DELIVERY SHAFT. NO DAMAGES WERE NOTED IN THE DEVICE. THE GAP BETWEEN THE LOCK OUT PLATE AND THE INDICATOR WINDOW WAS OBSERVED (AS EXPECTED). NO OBSTRUCTIONS, LOOSE OR BROKEN PARTS WERE OBSERVED. INDICATOR WINDOW ACHIEVED DIFFERENT POSITIONS BY MOVING THE LOCK OUT PLATE. AN ATTEMPT TO REMOVE THE RESIDUES OF DRIED BLOOD WAS MADE, HOWEVER IT WAS NOT POSSIBLE TO DO SO, THEREFORE FUNCTIONAL TEST COULD NOT BE PERFORMED. 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 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. IN THIS CASE, THE WINDOW CHANGED TO SOLID BLACK UPON RETRACTION OF THE DEVICES AS PER IFU, HOWEVER THERE WAS NO REDUCTION IN PULSATILE FLOW OBSERVED. THEREFORE, THE PHYSICIAN ACTED IN ACCORDANCE WITH THE IFU AND REMOVED THE SHEATH AND VCD TOGETHER AND PROCEEDED TO MANUAL COMPRESSION. THE IFU ALSO INSTRUCTS TO NOT USE THE EXOSEAL VCD TO CLOSE ARTERIOTOMIES CREATED IN AREAS OF CALCIFIED PLAQUE OR STENTED SEGMENTS. THE INDICATOR WIRE HAS THE POTENTIAL TO CATCH IN THE CALCIFICATION INSTEAD OF THE VESSEL WALL LEADING TO A FALSE INDICATOR WINDOW READING. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE VESSEL CHARACTERISTICS (CALCIFICATION) THAT MAY HAVE CONTRIBUTED TO THE REPORTED CHANGE IN INDICATOR WINDOW COLOR BEFORE THERE WAS A REDUCTION IN BLOOD FLOW FROM THE BLEED BACK INDICATOR. THE REPORTED NO REDUCTION IN FLOW COULD NOT BE CONFIRMED SINCE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO RESIDUES OF DRIED BLOOD FOUND IN THE DELIVERY SHAFT. THE REPORTED INDICATOR WINDOW- INCORRECT INDICATION WAS NOT CONFIRMED SINCE FUNCTIONAL TEST WAS SUCCESSFULLY PERFORMED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURES ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE USE OF AN EXOSEAL VASCULAR CLOSURE DEVICE, IT WAS REPORTED THAT, ALTHOUGH THE INDICATOR WINDOW CHANGED TO BLACK-BLACK PATTERN, THE PULSATILE FLOW FROM BLEED BACK INDICATOR WOULD NOT SIGNIFICANTLY SLOW. THEREFORE, THE EXOSEAL WITH THE SHEATH INTRODUCER WAS REMOVED FROM THE PATIENT WITHOUT PLUG PLACEMENT AND HOMEOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. NO BLEEDING COMPLICATIONS OCCURRED DURING AND AFTER THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THERE IS NO INFORMATION AVAILABLE ON THE PATIENT. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5MM IN DIAMETER. THERE WAS NO STENT NEAR THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE DEVICE OR MANUAL COMPRESSION LESS THAN 30 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. THERE WAS MODERATE CALCIFICATION WITH NO STENOSIS OBSERVED AT THE APPROACH SITE. THE EXOSEAL VCD WAS PREPPED ACCORDING TO IFU INSTRUCTIONS AND THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE FEMORAL ARTERY WAS ACCESSED WITH A 4.5F PARENT SHEATH INTRODUCER. AN ANTEGRADE APPROACH WAS USED. AFTER THE PTA, THE SHEATH INTRODUCER WAS EXCHANGED FOR A 6F BRITE TIP AND THE EXOSEAL WERE INSERTED INTO THE SHEATH INTRODUCER WITH NO DIFFICULTY. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED AS THE EXOSEAL VCD WAS ADVANCED THROUGH THE SHEATH. THE EXOSEAL VCD SECURELY LOCKED WITH THE VASCULAR SHEATH INTRODUCER. THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER RETRACTED TOGETHER UNTIL THE INDICATOR WINDOW CHANGED TO SOLID BLACK COLOR. AT NO TIME DID THE INDICATOR WINDOW SHOW ANY RED COLOR DURING RETRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283987 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15804466

    Patients

    Seq Age Sex Outcome Treatment
    1