BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI AVANTI PLUS

    MDR report key: 1979962 · Received February 7, 2011

    Report

    Report Number
    9616099-2011-00080
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING USE THE TIP OF THE AVANTI SHEATH SEPARATED. IT WAS REPORTED THAT THE TIP OF THE 5F AVANTI SHEATH BROKE OFF. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE. THE DEVICE WAS SNAPPED TOGETHER WITHOUT DIFFICULTY AND FLUSHED WITHOUT ANY PROBLEMS. THE TIP BROKE OFF AFTER THE SHEATH WAS PLACED IN THE PATIENT AND THE DILATOR WAS BEING REMOVED BY THE PHYSICIAN. THE TIP DID NOT REMAIN IN THE PATIENT. AS THE DOCTOR WAS UNSNAPPING THE DILATOR FROM THE SHEATH THE TIP BROKE OFF. THIS CAUSED NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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. REVIEW OF LOT 13370436 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NON-CONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 13370436. THE MOLDING TIP PARAMETERS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE FPI AND LPI MOLDING RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE CANNULA MOLDING PARAMETERS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE CANNULA FPI AND LPI MOLDING RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. CALIBRATION DUE DATE RECORDED FOR MOLDING TIP MACHINE WITH EQUIPMENT ID: (B)(4) WERE REVIEWED, AND IT WAS FOUND THAT THE MOLDING TIP MACHINE WAS CALIBRATED IN A TIMELY MANNER. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE CALIBRATION DATES. PREVENTIVE MAINTENANCE RECORD FOR MOLDING MACHINE WITH EQUIPMENT ID: (B)(4) WAS REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE 5F AVANTI SHEATH BROKE OFF. DEVICE WAS OPENED IN A STERILE FIELD AND WAS NOT USED IN THE PATIENT. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE. THEY SNAPPED IT TOGETHER WITHOUT DIFFICULTY AND FLUSHED WITHOUT ANY PROBLEMS. THE TIP BROKE OFF AFTER THE SHEATH WAS INSERTED AND THEY TRIED TO REMOVE THE DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI AVANTI PLUS CARDIOLOGY VASCULAR ACCESS (DRE) DRE CORDIS DE MEXICO NA 13370436

    Patients

    Seq Age Sex Outcome Treatment
    1