BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 1960145 · Received January 13, 2011

    Report

    Report Number
    9616099-2011-00037
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE BUT HAS NOT BEEN RECEIVED AS OF THE INITIAL REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED THE PRODUCT BOX AND STERILE PACKAGING BOTH INDICATED THIS WAS A 6 X 30 PRECISE OTW STENT. WHEN SCRUB TECH LOOKED AT PRODUCT CATHETER BEFORE LOADING OVER THE WIRE, THE CATHETER INDICATED THIS WAS A 7 X 30 STENT. CUSTOMER IS UNSURE WHAT THE TRUE SIZE OF THE STENT IS (IT WAS NEVER DEPLOYED) BUT THE SIZE ON PRODUCT PACKAGING IS NOT CONSISTENT WITH THE SIZE ON THE CATHETER ITSELF. ONE NON-STERILE UNIT OF PRECISE BILIARY 6X30 MM WAS RECEIVED COILED IN A PLASTIC BAG; THE PACKAGING INNER AND OUTER LABELS WERE RECEIVED IN THE SAME PLASTIC BAG. THE STENT WAS NOT DEPLOYED. DURING THE VISUAL ANALYSIS IT WAS DETECTED THAT INNER AND OUTER LABEL INDICATED THAT STENT SIZE WAS 6X30 MM AND ID BAND INDICATED THAT STENT SIZE WAS 7X30 MM. STENT WAS DEPLOYED AND THE OUTER DIAMETER (OD) WAS MEASURED; STENT OD WAS MEASURED IN 4 DIFFERENT PLACES AND THE AVERAGE OF THE STENT OD WAS 6.2404 MM, WHICH IS WITHIN SPECIFICATION AND MATCH WITH THE PACKAGING OUTER AND INNER LABELS. THE FAILURE REPORTED BY THE CUSTOMER - LABELING "INCORRECT" WAS CONFIRMED DUE TO STENT SIZE OF ID BAND DOES NOT MATCH TO THE PRODUCT AND PACKAGING LABELING AND PER ANALYSIS RESULTS IT IS CONSIDERED MANUFACTURING RELATED ISSUE. THE CAUSE OF THE INCORRECT ID BAND ASSEMBLED ON PRODUCT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS; HOWEVER IT COULD BE RELATED TO A LINE CLEARNESS PROCEDURE NOT PROPERLY FOLLOWED. AWARENESS TRAINING WAS CONDUCTED ON (B)(4) 2011, TO THE MANUFACTURING ASSOCIATES IN ORDER TO REINFORCE THE CONTROLS THAT ARE IN PLACE TO VERIFY THE CATHETER FOR CORRECT STENT SIZE ON ID BAND AND TO PREVENT THE COMMINGLING THROUGH THE MANUFACTURING PROCESS. (B)(4) HAS BEEN OPENED IN ORDER TO PERFORM THE RISK ASSESSMENT OF DISTRIBUTED PRODUCT. THIS HAS BEEN IDENTIFIED AS A MANUFACTURING RELATED ISSUE AND RISK CONTROL MEASURES HAVE BEEN INITIATED.

    Description of Event or Problem · 1

    AS REPORTED BY SALES REP, PRODUCT BOX AND STERILE PACKAGING BOTH INDICATED THIS WAS A 6 X 30 PRECISE OTW STENT. WHEN SCRUB TECH LOOKED AT PRODUCT CATHETER BEFORE LOADING OVER THE WIRE, THE CATHETER INDICATED THIS WAS A 7 X 30 STENT. CUSTOMER IS UNSURE WHAT THE TRUE SIZE OF THE STENT IS (IT WAS NEVER DEPLOYED) BUT THE SIZE ON PRODUCT PACKAGING IS NOT CONSISTENT WITH THE SIZE ON THE CATHETER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 15104092

    Patients

    Seq Age Sex Outcome Treatment
    1