BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI AVANTI PLUS

    MDR report key: 4200314 · Received October 24, 2014

    Report

    Report Number
    9616099-2014-00687
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 1, 2014
    Report Date
    December 4, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. 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. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A REPORT WAS RECEIVED OF AN ¿EXTRA¿ PIECE OF PLASTIC ON THE HUB OF A 4F AVANTI+ CATHETER SHEATH INTRODUCER. THE SITE REPORTED THAT THEY WERE CONCERNED THAT THIS PIECE COULD BREAK OFF AND BE INTRODUCED INTO A PATIENT. A PROVIDED PICTURE REVEALED A PIECE OF MATERIAL OF THE HUB OF A VESSEL DILATOR. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. BASED ON THE DHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE FACILITY, THERE IS AN ¿EXTRA¿ PIECE OF PLASTIC ON THE HUB OF THE INTRODUCER OF A 4F 11CM AVANTI PLUS. THE REPORTER IS CONCERNED THIS COULD BREAK OFF AND BE INTRODUCED INTO A PATIENT. HE STATED THIS IS A SIMILAR ISSUE HE EXPERIENCED A FEW WEEKS AGO. A PICTURE OF THE INTRODUCER IS ATTACHED. THE PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679679 SI AVANTI PLUS CARDIOLOGY VASCULAR ACCESS (DRE) DRE CORDIS CORPORATION 504604A 15954194

    Patients

    Seq Age Sex Outcome Treatment
    1