BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 2801737 · Received October 23, 2012

    Report

    Report Number
    9616099-2012-00575
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    August 16, 2012
    Report Date
    September 12, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS IT WAS REPORTED BY AN AFFILIATE, DURING AN INTERVENTIONAL PROCEDURE, AN EXOSEAL (VCD) DEVICE (6F) WITHOUT VISIBLE SIGNS OF DAMAGE WAS USED IN AN ANTEGRADE APPROACH DID NOT ACHIEVE HEMOSTASIS AND CAUSED A HEMATOMA. THE DEVICE WAS USED FOR HEMOSTASIS OF A HEAVILY CALCIFIED ACCESS SITE AFTER THE PTA FOR CTO LESION SUPERFICIAL FEMORAL ARTERY, WITH A VESSEL DIAMETER GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. THE ARTERIOTOMY WAS NEAR AN AREA OF CALCIFIED PLAQUE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED AS THE VCD WAS ADVANCED THROUGH THE SHEATH. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING. AS PER AFFILIATE, IT WAS UNCERTAIN IF AN AUDIBLE "CLICK" WAS HEARD; BUT THE SHEATH INTRODUCER AND THE SHEATH ADAPTER WERE CONNECTED PROPERLY AND THERE WAS NO GAP. ADEQUATE BLEED-BACK AND PROPER INDICATION IN THE WINDOW WAS OBSERVED. A GUIDING SHEATH (PARENT 6F) WHICH WAS INITIALLY USED FOR THE PTA WAS EXCHANGED FOR A SHORT SHEATH (TERUMO'S 6F 11 CM). EXOSEAL (6F) WAS INSERTED INTO THE SHORT SHEATH, THE PLUG DEPLOYMENT BUTTON FULLY DEPRESSED AND THE PLUG WAS DEPLOYED AT THE VASCULAR ACCESS SITE WITHOUT ANY ISSUES. THE LIGHT PRESSURE WAS APPLIED, BUT PULSATILE BLOOD FLOW APPEARED FROM THE WOUND SITE. THEN, THE PHYSICIAN APPLIED MANUAL PRESSURE TO ACHIEVE HEMOSTASIS. IT TOOK APPROX 8 MIN TO ACHIEVE HEMOSTASIS, AND ADDITIONAL 20 MIN MANUAL PRESSURE WAS APPLIED. HOWEVER, A HEMATOMA WAS CONFIRMED AT THE WOUND SITE, AND THE PATIENT STAYED IN THE HOSPITAL AND WAS FOLLOWED UP. AS PER THE AFFILIATE THE HEMATOMA WAS CAUSED BY THE PATIENT'S BLOOD PRESSURE WAS 280 MMHG, AND THIS MIGHT BE DIFFICULT TO STOP THE BLEEDING EVEN IF MANUAL PRESSURE WAS APPLIED. TWO DAYS AFTER THE PROCEDURE THE HEMATOMA WAS SURGICALLY REMOVED AND ANGIOGRAPHY WAS CONDUCTED. THE PATIENT WAS DISCHARGED A WEEK AFTER THE PROCEDURE AFTER MAKING SATISFACTORY PROGRESS. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THE PHYSICIAN'S EXPERIENCE WITH EXOSEAL IS UNKNOWN. 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. 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. ACCESS SITE HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. THESE FACTORS IN COMBINATION WITH ANTIPLATELET THERAPY AFTER A PROCEDURE CAN LEAD TO HEMATOMAS. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (BLOOD PRESSURE 280 MMHG), PROCEDURAL (ANTEGRADE APPROACH) AND/OR PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE. BASED ON THE AVAILABLE INFORMATION AND THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. NOTE: THIS COMPLAINT WAS INITIALLY SUBMITTED ON (B)(4) 2012, BUT WAS REJECTED.

    Description of Event or Problem · 1

    AS IT WAS REPORTED BY AN AFFILIATE, DURING AN INTERVENTIONAL PROCEDURE, AN EXOSEAL (VCD) DEVICE (6F) WITHOUT VISIBLE SIGNS OF DAMAGE WAS USED IN AN ANTEGRADE APPROACH DID NOT ACHIEVE HEMOSTASIS AND CAUSED A HEMATOMA. THE DEVICE WAS USED FOR HEMOSTASIS OF A HEAVILY CALCIFIED ACCESS SITE AFTER THE PTA FOR CTO LESION SUPERFICIAL FEMORAL ARTERY, WITH A VESSEL DIAMETER GREATER THAN OR EQUAL TO 5MM IN DIAMETER. THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. THE ARTERIOTOMY WAS NEAR AN AREA OF CALCIFIED PLAQUE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED AS THE VCD WAS ADVANCED THROUGH THE SHEATH. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING. AS PER AFFILIATE, IT WAS UNCERTAIN IF AN AUDIBLE "CLICK" WAS HEARD; BUT THE SHEATH INTRODUCER AND THE SHEATH ADAPTER WERE CONNECTED PROPERLY AND THERE WAS NO GAP. ADEQUATE BLEED-BACK AND PROPER INDICATION IN THE WINDOW WAS OBSERVED. A GUIDING SHEATH (PARENT 6F) WHICH WAS INITIALLY USED FOR THE PTA WAS EXCHANGED FOR A SHORT SHEATH (TERUMO'S 6F 11CM). EXOSEAL (6F) WAS INSERTED INTO THE SHORT SHEATH, THE PLUG DEPLOYMENT BUTTON FULLY DEPRESSED AND THE PLUG WAS DEPLOYED AT THE VASCULAR ACCESS SITE WITHOUT ANY ISSUES. THE LIGHT PRESSURE WAS APPLIED, BUT PULSATILE BLOOD FLOW APPEARED FROM THE WOUND SITE. THEN, THE PHYSICIAN APPLIED MANUAL PRESSURE TO ACHIEVE HEMOSTASIS. IT TOOK APPROX 8MIN TO ACHIEVE HEMOSTASIS, AND ADDITIONAL 20MIN MANUAL PRESSURE WAS APPLIED. HOWEVER, A HEMATOMA WAS CONFIRMED AT THE WOUND SITE, AND THE PATIENT STAYED IN THE HOSPITAL AND WAS FOLLOWED UP. AS PER THE AFFILIATE THE HEMATOMA WAS CAUSED BY THE PATIENT'S BLOOD PRESSURE WAS 280MMHG, AND THIS MIGHT BE DIFFICULT TO STOP THE BLEEDING EVEN IF MANUAL PRESSURE WAS APPLIED. TWO DAYS AFTER THE PROCEDURE THE HEMATOMA WAS SURGICALLY REMOVED AND ANGIOGRAPHY WAS CONDUCTED. THE PATIENT WAS DISCHARGED A WEEK AFTER THE PROCEDURE AFTER MAKING SATISFACTORY PROGRESS. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THE PHYSICIAN EXPERIENCE WITH EXOSEAL IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15582045

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization