BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3820064 · Received May 20, 2014

    Report

    Report Number
    9616099-2014-00331
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 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

    COMPLAINT CONCLUSION: DURING USE OF A 6F EXOSEAL FOR VASCULAR CLOSURE, IT WAS REPORTED THAT WHEN THE EXOSEAL VCD AND SHEATH INTRODUCER WERE RETRACTED AFTER DEPLOYMENT OF THE INDICATOR WIRE, THE GRAPHIC PATTERN IN THE INDICATOR WINDOW WAS UNSTABLY CHANGED TO BLACK-BLACK OR BLACK-WHITE. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WAS NO PATIENT INJURY REPORTED. THE EXOSEAL VCD WAS USED FOR HEMOSTASIS AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). RETROGRADE APPROACH WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS UNKNOWN. FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY. THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. THE ARTERIOTOMY WAS NOT IN OR NEAR AN AREA OF CALCIFIED PLAQUE OR NEAR A STENTED SEGMENT. THE VESSEL DIAMETER WAS >/= TO 5MM IN DIAMETER. 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. ).. THE VCD SHOWED NO VISIBLE SIGNS OF DAMAGE AND WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. A 6F UNKNOWN SHEATH WAS USED. NO OTHER SHEATHS WERE USED DURING THE PROCEDURE. AFTER THE PTA, THE EXOSEAL WAS INSERTED INTO A SHEATH INTRODUCER (6F/10CM TERUMO SHEATH THERE WAS NO RESISTANCE/FRICTION EXPERIENCED AS THE VCD WAS ADVANCED THROUGH THE SHEATH. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING AND AN AUDIBLE ¿CLICK¿ HEARD. THE EXOSEAL VCD AND SHEATH INTRODUCER WERE RETRACTED AFTER DEPLOYMENT OF THE INDICATOR WIRE, BUT THE GRAPHIC PATTERN IN THE INDICATOR WINDOW WAS UNSTABLY CHANGED TO BLACK-BLACK OR BLACK-WHITE. AS THE PHYSICIAN JUDGED THAT THE INDICATOR WIRE MIGHT BE CAUGHT IN AN IMPLANTED STENT AND MADE THE EXOSEAL VCD RETRACT WITH BEING ROTATED, THE DISAPPEARANCE OF THE PULSATILE FLOW FROM BLEED BACK INDICATOR WAS NOT PRECISELY CONFIRMED. THEREFORE, HE STOPPED USING THE DEVICE. THERE WAS NO BLEEDING COMPLICATION DURING OR AFTER THE PROCEDURE. THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD, BUT IT IS UNKNOWN HOW MANY TIMES THE PHYSICIAN HAS USED TO EXOSEAL VCD PRIOR TO THIS PROCEDURE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT ¿INDICATOR WINDOW-INCORRECT INDICATION¿ COULD NOT BE CONFIRMED. THE IFU RECOMMENDS THAT DURING RETRACTION OF THE EXOSEAL DEVICE AND THE SHEATH AS A SINGLE UNIT IT IS IMPORTANT TO ENSURE THAT THE OPERATOR¿S THUMB IS NOT PLACED OR RESTING ON THE PLUG DEPLOYMENT BUTTON (PER PROCEDURE STEP 7 IN THE EXOSEAL INSTRUCTIONS FOR USE). 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 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. THE PHYSICIAN JUDGED THAT ¿THE INDICATOR WIRE MAY BE CAUGHT ON AN IMPLANTED STENT¿. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS POSSIBLE THAT VESSEL CHARACTERISTICS (STENT NEAR THE ARTERIOTOMY SITE) MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGEST THAT THE REPORTED FAILURE COULD BE RELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUED: THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD, BUT IT IS UNKNOWN HOW MANY TIMES THE PHYSICIAN HAS USED TO EXOSEAL VCD PRIOR TO THIS PROCEDURE. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING USE OF A 6F EXOSEAL FOR VASCULAR CLOSURE, IT WAS REPORTED THAT WHEN THE EXOSEAL VCD AND SHEATH INTRODUCER WERE RETRACTED AFTER DEPLOYMENT OF THE INDICATOR WIRE, THE GRAPHIC PATTERN IN THE INDICATOR WINDOW WAS UNSTABLY CHANGED TO BLACK-BLACK OR BLACK-WHITE. AS THE PHYSICIAN JUDGED THAT THE INDICATOR WIRE MIGHT BE CAUGHT IN AN IMPLANTED STENT AND MADE THE EXOSEAL VCD RETRACT WITH BEING ROTATED, THE DISAPPEARANCE OF THE PULSATILE FLOW FROM BLEED BACK INDICATOR WAS NOT PRECISELY CONFIRMED. THEREFORE, HE STOPPED USING THE DEVICE. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WAS NO BLEEDING COMPLICATION DURING OR AFTER THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. THE EXOSEAL VCD WAS USED FOR HEMOSTASIS AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). RETROGRADE APPROACH WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS UNKNOWN. AFTER THE PTA, THE EXOSEAL WAS INSERTED INTO A SHEATH INTRODUCER (6F/10CM TERUMO SHEATH). FEMORAL ARTERY SUITABILITY WAS VERIFIED ON ANGIOGRAPHY. THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. THE ARTERIOTOMY WAS NOT IN OR NEAR AN AREA OF CALCIFIED PLAQUE OR NEAR A STENTED SEGMENT. THE VESSEL DIAMETER WAS >/= TO 5MM IN DIAMETER. 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. THE VCD SHOWED NO VISIBLE SIGNS OF DAMAGE AND WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. A 6F UNKNOWN SHEATH WAS USED. NO OTHER SHEATHS WERE USED DURING THE PROCEDURE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED AS THE VCD WAS ADVANCED THROUGH THE SHEATH. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING AND AN AUDIBLE ¿CLICK¿ HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300330 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15944882

    Patients

    Seq Age Sex Outcome Treatment
    1 6F 10CM TERUMO SHEATH