BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3790180 · Received May 5, 2014

    Report

    Report Number
    9616099-2014-00299
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    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

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS. THEREFORE, WERE UPDATED. DURING USE OF A 6F EXOSEAL FOR VASCULAR CLOSURE, THE PULSATILE FLOW FROM THE BLEED BACK INDICATOR NEVER STOPPED ALTHOUGH THE INDICATOR WINDOW SHOWED SOLID BLACK. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE EXOSEAL WAS USED FOR HEMOSTASIS AFTER PCI; THE TARGET LESION WAS THE FEMORAL ARTERY. RETROGRADE APPROACH WAS USED IN THE PROCEDURE. THE INSERTION ANGLE WAS KEPT BETWEEN 30-40 DEGREES. THERE WAS NO CALCIFICATION AND TORTUOSITY. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE BLEED-BACK INDICATOR WAS NOT VISIBLY DAMAGED. THE EXOSEAL VCD WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. THE BRAND AND SIZE OF SHEATH USED WAS UNKNOWN. AFTER THE PCI, THE EXOSEAL WAS INSERTED INTO A SHEATH INTRODUCER, AND THE EXOSEAL WITH THE SHEATH INTRODUCER WAS RETRACTED AS A UNIT. HOWEVER, THE PULSATILE FLOW FROM BLEED BACK INDICATOR NEVER STOPPED ALTHOUGH THE INDICATOR WINDOW SHOWED SOLID BLACK. THE EXOSEAL WITH THE SHEATH INTRODUCER WAS REMOVED FROM THE PATIENT WITHOUT PLUG PLACEMENT. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. THERE WAS NO BLEEDING COMPLICATION DURING OR AFTER THE PROCEDURE. THE PHYSICIAN EXPERIENCED OVER (B)(4) CASES WITH EXOSEAL. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 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. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINTS BLEED BACK INDICATOR-NO REDUCTION IN FLOW AND INDICATOR WINDOW-INCORRECT INDICATION COULD NOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING USE OF A 6F EXOSEAL FOR VASCULAR CLOSURE, THE PULSATILE FLOW BLEED BACK INDICATOR NEVER STOPPED THOUGH THE INDICATOR WINDOW SHOWED SOLID BLACK. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE EXOSEAL WAS USED FOR HEMOSTASIS AFTER PCI; THE TARGET LESION WAS THE FEMORAL ARTERY. THERE WAS NO CALCIFICATION AND TORTUOSITY. AFTER THE PCI, THE EXOSEAL WAS INSERTED INTO A SHEATH INTRODUCER, AND THE EXOSEAL WITH THE SHEATH INTRODUCER WAS RETRACTED AS A UNIT. HOWEVER, THE PULSATILE FLOW FROM BLEED BACK INDICATOR NEVER STOPPED, ALTHOUGH THE INDICATOR WINDOW SHOWED SOLID BLACK. THE EXOSEAL WITH THE SHEATH INTRODUCER CAME OUT OF THE PATIENT WITHOUT PLUG PLACEMENT. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. NO BLEEDING COMPLICATION OCCURRED DURING AND AFTER THE PROCEDURE. THE INSERTION ANGLE WAS KEPT BETWEEN 30-40 DEGREES. THE PHYSICIAN EXPERIENCED OVER 50 CASES WITH EXOSEAL. IT WILL BE RETURNED FOR ANALYSIS. RETROGRADE APPROACH WAS USED IN THE PROCEDURE. THE EXOSEAL VCD WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE BRAND AND SIZE OF SHEATH USED WAS UNKNOWN. PULSATILE FLOW WAS OBSERVED FROM THE BLEED-BACK INDICATOR WHICH WAS NOT VISIBLY DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267161 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15983153

    Patients

    Seq Age Sex Outcome Treatment
    1