BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI AVANTI PLUS

    MDR report key: 3181376 · Received June 21, 2013

    Report

    Report Number
    9616099-2013-00387
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 27, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY AN AFFILIATE, DURING AN ARTERIAL ARTERIOGRAPHY OF THE VESSELS IN THE LEGS, THE AVANTI+ CANNULA DETACHED WITHIN THE BODY OF THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY. INITIALLY, THERE WAS AN EASY PUNCTURE OF LEFT FEMORAL ARTERY AND THE AVANTI+ SHEATH WAS INTRODUCED WITHOUT EXCESSIVE RESISTANCE. WHEN PULLING THE OBTURATOR WITH REMAINING GUIDEWIRE, PROFUSE BLEEDING OCCURRED DUE TO THE TOP OF THE HEMOSTATIS VALVE BECOMING DETACHED FROM THE SHEATH. FOLLOWING PROLONGED COMPRESSION OF THE PUNCTURE SITE, A BALLOON CATHETER WAS SUCCESSFULLY PLACED INSIDE THE SHEATH OVER THE GUIDEWIRE AND INFLATED AT 6ATM, THUS FIXATING THE SHEATH TO BE PULLED OUT. THIS WAS DETERMINED TO BE THE ONLY WAY TO AVOID VASCULAR PROCEDURES WITH ADDITIONAL RISKS FOR THE PATIENT. ONE NON-STERILE 6F SHEATH INTRODUCER WAS RECEIVED. THE CANNULA WAS RECEIVED SEPARATED FROM THE HUB. NO VISUAL ANOMALIES SUCH AS ELONGATION OR ANY TYPE OF DAMAGES WERE FOUND AT THE SEPARATION POINT. NO EVIDENCE OF MATERIAL TRANSFER BETWEEN COMPONENTS (CANNULA AND HUB) WAS FOUND. NO FURTHER VISUAL ANOMALIES WERE FOUND. THE INNER AND OUTER CANNULA DIAMETERS WERE MEASURED NEAR THE SEPARATION POINT AND WERE FOUND WITHIN SPECIFICATION. THE CANNULA SEPARATION WAS RECREATED AT THE MOLDING PROCESS. THIS SEPARATION CAN BE RECREATED IF THE TUBE IS NOT COMPLETELY SLID TO THE END OF THE GAUGE PIN. REVIEW OF LOT 15761742 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE CANNULA SEPARATION REPORTED BY THE CUSTOMER WAS CONFIRMED DURING ANALYSIS AND WAS DETERMINED TO BE RELATED TO THE MOLDING PROCESS. AN INTERNAL RISK ASSESSMENT HAS BEEN OPENED TO EVALUATE THIS.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING AN ARTERIAL ARTERIOGRAPHY OF THE VESSELS IN THE LEGS, THE TIP OF AN AVANTI PLUS SHEATH DETACHED WITHIN THE BODY OF THE PATIENT, BUT REMAINED ON THE GUIDEWIRE. IT WAS RETRIEVED WITH HELP OF THE PTA BALLOON CATHETER. THERE WAS NO REPORT OF PATIENT INJURY. INITIALLY, EASY PUNCTURE OF LEFT FEMORAL ARTERY AND INTRODUCTION OF AVANTI SHEATH WITHOUT EXCESSIVE RESISTANCE. WHEN PULLING THE OBTURATOR WITH REMAINING GUIDEWIRE, PROFUSE BLEEDING STARTED DUE TO THE TOP OF THE HEMOSTATIC VALVE BECOMING DETACHED FROM THE SHEATH. PUNCTURE SITE GOT COMPRESSED FOR A PROLONGED TIME AND AFTERWARDS A BALLOON CATHETER WAS SUCCESSFULLY PLACED INSIDE THE SHEATH OVER THE GUIDEWIRE AND INFLATED WITH 6 BAR, THUS GETTING FIXATED IN THE SHEATH TO PULL EVERYTHING TOGETHER OUT. THIS WAS THE ONLY WAY TO AVOID VASCULAR PROCEDURES WITH ADDITIONAL RISKS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282118 SI AVANTI PLUS CARDIOLOGY VASCULAR ACCESS (DRE) DRE CORDIS DE MEXICO NA 15761742

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R