BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3941381 · Received July 17, 2014

    Report

    Report Number
    9616099-2014-00476
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 23, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE DAY AFTER SUCCESSFUL DEPLOYMENT OF A 6 FR. EXOSEAL VASCULAR CLOSURE DEVICE (VCD), THE PHYSICIAN REMOVED THE PATIENT¿S COMPRESSION BANDAGING AND ALLOWED THE PATIENT TO END BED REST. THREE HOURS LATER, THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED DISTURBANCE OF CONSCIOUSNESS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND BLEEDING FROM THE PUNCTURE SITE AND RETROPERITONEAL BLEEDING HAD OCCURRED. THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT INTUBATED AND UNCONSCIOUS. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE LEFT SUPERFICIAL FEMORAL ARTERY (LSFA). THE ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. ARTERIAL ACCESS WAS OBTAINED USING A NON-CORDIS SHORT SHEATH. THE SHORT SHEATH WAS THEN EXCHANGED FOR A NON-CORDIS 55 CM. GUIDING SHEATH. AFTER THE PTA, THE GUIDING SHEATH WAS RE-EXCHANGED FOR THE NON-CORDIS SHORT SHEATH. THE EXOSEAL DEVICE WAS INSERTED INTO THE SHEATH. PLUG DEPLOYMENT WAS CONDUCTED AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT KEPT QUIET WITH COMPRESSION BANDAGING ON THE PUNCTURE SITE. THERE WERE NO REPORTED SIGNS OF BLEEDING OR HEMATOMA NOTED AFTER REMOVAL OF THE PATIENT¿S PRESSURE BANDAGING. THE PATIENT¿S BLOOD PRESSURE AND ACTIVITY LEVEL WHEN THE BLEEDING STARTED WERE NOT KNOWN. THE PATIENT WAS NOT SYMPTOMATIC AT ALL PRIOR TO BEING ALLOWED OUT OF BED AFTER REMOVAL OF THE PRESSURE BANDAGING. THERE WERE NO REPORTED PRODUCT ISSUES NOTED DURING DEPLOYMENT OF THE EXOSEAL. THERE WAS NO SUSPICION OF INTRAVASCULAR DEPLOYMENT. HEMOSTASIS WAS THOUGHT TO HAVE BEEN SUCCESSFULLY ACHIEVED AFTER PLUG DEPLOYMENT AND LIGHT COMPRESSION. THERE WAS NO PULSATILE BLEEDING OF THE PUNCTURE SITE NOTED UPON REMOVAL OF THE EXOSEAL DEVICE AND SHEATH. MULTIPLE STICKS WERE NOT MADE WHILE ATTEMPTING TO OBTAIN VASCULAR ACCESS. THE APPROACH WAS RETROGRADE. THE PHYSICIAN WAS CERTIFIED FOR USE OF THE DEVICE, THE NUMBER OF CASES PERFORMED WAS UNKNOWN. NO VISIBLE SIGNS OF DAMAGE WERE NOTED TO THE PACKAGING OR THE DEVICE UPON INSPECTION PRIOR TO USE. THE VCD WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). 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. THERE WAS NO REPORTED DIFFICULTY CONNECTING THE SHEATH WITH THE EXOSEAL DEVICE. THERE WAS NO REPORTED DIFFICULTY DEPLOYING THE PLUG. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. BASED ON THE INFORMATION PROVIDED AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE EXOSEAL IFU LISTS PROLONGED ACCESS SITE-RELATED BLEEDING AS A POTENTIAL RISK ASSOCIATED WITH FEMORAL ARTERY CLOSURE PROCEDURES. ACCESS SITE BLEEDS, HEMATOMAS, AND RETROPERITONEAL BLEEDS ARE COMMON PROCEDURAL COMPLICATIONS AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. PATIENT AND/OR PHARMACOLOGICAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. ADEQUATE SHEATH REMOVAL TECHNIQUE AND PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION ARE ROOT CAUSES OF PSEUDOANEURYSM AND HEMATOMA FORMATION. AS PER THE REPORT, PLUG DEPLOYMENT WAS CONDUCTED AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT KEPT QUIET WITH COMPRESSION BANDAGING ON THE PUNCTURE SITE. THERE WERE NO REPORTED SIGNS OF BLEEDING OR HEMATOMA NOTED AFTER REMOVAL OF THE PATIENT¿S PRESSURE BANDAGING. THE PATIENT¿S BLOOD PRESSURE AND ACTIVITY LEVEL WHEN THE BLEEDING STARTED WERE NOT KNOWN. THE PATIENT WAS NOT SYMPTOMATIC AT ALL PRIOR TO BEING ALLOWED OUT OF BED AFTER REMOVAL OF THE PRESSURE BANDAGING. WITHOUT THE RETURN OF THE ACTUAL COMPLAINT PRODUCT THE EVENT REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED, NOR CAN ANY CONCLUSION REGARDING ROOT CAUSE BE DRAWN. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: SHEATHS:GOODMAN 6F/11CM; ASAHI INTECC 6F/55CM GUIDING SHEATH. THERE WERE NO REPORTED SIGNS OF BLEEDING OR HEMATOMA NOTED AFTER REMOVAL OF THE PATIENT¿S PRESSURE BANDAGING. THE PATIENT¿S BLOOD PRESSURE AND ACTIVITY LEVEL WHEN THE BLEEDING STARTED WERE NOT KNOWN. THE PATIENT WAS NOT SYMPTOMATIC AT ALL PRIOR TO BEING ALLOWED OUT OF BED AFTER REMOVAL OF THE PRESSURE BANDAGING. THERE WERE NO REPORTED PRODUCT ISSUES NOTED DURING DEPLOYMENT OF THE EXOSEAL. THERE WAS NO SUSPICION OF INTRAVASCULAR DEPLOYMENT. HEMOSTASIS WAS THOUGHT TO HAVE BEEN SUCCESSFULLY ACHIEVED AFTER PLUG DEPLOYMENT AND LIGHT COMPRESSION. THERE WAS NO PULSATILE BLEEDING OF THE PUNCTURE SITE NOTED UPON REMOVAL OF THE EXOSEAL DEVICE AND SHEATH. MULTIPLE STICKS WERE NOT MADE WHILE ATTEMPTING TO OBTAIN VASCULAR ACCESS. THE APPROACH WAS RETROGRADE. THE PHYSICIAN WAS CERTIFIED FOR USE OF THE DEVICE, THE NUMBER OF CASES PERFORMED WAS UNKNOWN. NO VISIBLE SIGNS OF DAMAGE WERE NOTED TO THE PACKAGING OR THE DEVICE UPON INSPECTION PRIOR TO USE. THE VCD WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). 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. THERE WAS NO REPORTED DIFFICULTY CONNECTING THE SHEATH WITH THE EXOSEAL DEVICE. THERE WAS NO REPORTED DIFFICULTY DEPLOYING THE PLUG. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE DAY AFTER SUCCESSFUL DEPLOYMENT OF A 6 FR. EXOSEAL VASCULAR CLOSURE DEVICE (VCD), THE PHYSICIAN REMOVED THE PATIENT¿S COMPRESSION BANDAGING AND ALLOWED THE PATIENT TO END BED REST. THREE HOURS LATER, THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED DISTURBANCE OF CONSCIOUSNESS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND BLEEDING FROM THE PUNCTURE SITE AND RETROPERITONEAL BLEEDING HAD OCCURRED. THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT INTUBATED AND UNCONSCIOUS. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE LEFT SUPERFICIAL FEMORAL ARTERY (LSFA). THE ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. ARTERIAL ACCESS WAS OBTAINED USING A NON-CORDIS SHORT SHEATH. THE SHORT SHEATH WAS THEN EXCHANGED FOR A NON-CORDIS 55 CM. GUIDING SHEATH. AFTER THE PTA, THE GUIDING SHEATH WAS RE-EXCHANGED FOR THE NON-CORDIS SHORT SHEATH. THE EXOSEAL DEVICE WAS INSERTED INTO THE SHEATH. PLUG DEPLOYMENT WAS CONDUCTED AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT KEPT QUIET WITH COMPRESSION BANDAGING ON THE PUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418731 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15965979

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R