BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI AVANTI PLUS

    MDR report key: 3240514 · Received July 22, 2013

    Report

    Report Number
    9616099-2013-00464
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    August 23, 2012
    Report Date
    August 23, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING USE OF AN AVANTI PLUS 5F SHEATH IT WAS REPORTED THAT THE PRODUCT ¿SNAPPED¿ ALONG THE CIRCUMFERENTIAL WIDTH, AND BROKE INTO TWO PIECES IN THE RIGHT FEMORAL VEIN. ADDITIONAL DILATION OF THE SKIN PUNCTURE AND VEIN WERE REQUIRED IN ORDER TO REMOVE THE SHAFT TIP. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED PRIOR TO USE, AND NO ANOMALIES WERE NOTED. THERE HAD BEEN NO DIFFICULTY INSERTING THE SHEATH INTO THE VESSEL. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS, IT IS NOT POSSIBLE TO CONFIRM THIS COMPLAINT. IT IS ALSO NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE COMPLAINT BASED ON THE MINIMAL INFORMATION PROVIDED. THERE IS NO EVIDENCE THAT THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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

    DURING USE OF AN AVANTI PLUS 5F SHEATH IT WAS REPORTED THAT THE PRODUCT SNAPPED AND BROKE INTO TWO PIECES IN THE RIGHT FEMORAL VEIN. THE SHEATH SHAFT SNAPPED ALONG THE CIRCUMFERENTIAL WIDTH. UNNECESSARY DILATION OF PUNCTURE TO THE SKIN AND VEIN IN ORDER TO REMOVE SHAFT TIP WAS NEEDED. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO PRIOR HINT OF A WEAKNESS IN THE SHEATH BEFORE INSERTION. THERE WAS NO DIFFICULTY INSERTING THE SHEATH INTO THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340726 SI AVANTI PLUS CARDIOLOGY VASCULAR ACCESS (DRE) DRE CORDIS DE MEXICO NA 15543835

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R