BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ MEDIUM ON POWERFLEX PLUS

    MDR report key: 946991 · Received November 7, 2007

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    Report

    Report Number
    9610978-2007-00401
    Event Type
    Malfunction
    Date Received
    November 7, 2007
    Date of Event
    October 19, 2007
    Report Date
    October 19, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AFTER THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM FROM THE PACKAGE, HE TRIED TO RE-POSITION THE STENT ON THE BALLOON, HOWEVER, THE STENT "BROKE'. THERE WERE NO ANOMALIES NOTED WITH THE PRODUCT BEFORE REPOSITIONING THE STENT AND THERE WERE NO NOTED DEFECTS WITH THE PACKAGING. THIS COMPLAINT IS BEING REPORTED BECAUSE HAD THE MALFUNCTION OCCURRED INSIDE THE PATIENT, IT WOULD BE A REPORTABLE MALFUNCTION. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY USER HANDLING AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBERS WITH LOT NUMBER 0311060241, 0410060519 AND 0410060598. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL.

    Description of Event or Problem · 1

    AFTER OPENED THE STERILE PACKAGE, THE PHYSICIAN TRIED TO RE-MOUNT THE STENT OF THE PRODUCT (PALMAZ), BUT THE STENT BROKE. ANOTHER STENT (PALMAZ, SIZE: UNKNOWN) WAS USED FOR THE PROCEDURE AND THE PROCEDURES WAS SUCCESSFULLY COMPLETED. THERE WERE NO ANOMALIES NOTED WITH THE PRODUCT BEFORE REPOSITIONING THE STENT. THERE WERE NO NOTED DEFECTS WITH THE PACKAGING. THE PRODUCT WAS NOT CLINICALLY; THEREFORE, THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ MEDIUM ON POWERFLEX PLUS ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R1106094

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR