BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 1344179 · Received February 2, 2009

    Report

    Report Number
    3004742046-2009-00017
    Event Type
    Malfunction
    Date Received
    February 2, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 9, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE 5X40X80 AGILTRAC .035 WAS RETURNED WITH THE 7X20 CHIPBOARD BOX AND THE 7X20 OPENED POUCH. THE POUCH FLAP WAS COMPLETELY PEELED OFF AND WAS NOT RETURNED. THE BALLOON CATHETER LABELED SIDE ARM (5.0X40; LOT NUMBER 7041251) DID NOT MATCH THE SIZE AND LOT NUMBER LABELS ON BOTH THE CHIPBOARD BOX AND POUCH (PART #:1010007-20, SIZE: 7.0MMX20MMX 80CM AND LOT #: 7041051). THE RETURNED AGILTRAC CATHETER MEASUREMENTS FOR TOTAL LENGTH AND BALLOON OUTER DIAMETER AND BALLOON LENGTH WERE MEASURED AND MET MANUFACTURING CRITERIA FOR AN AGILTRAC .035 5.0MMX40MMX80CM BALLOON CATHETER. A REVIEW OF THE SHIPPING RECORDS DID NOT INDICATE THAT THE CUSTOMER RECEIVED THE SPECIFIC LOT OF 5.0MMX40MMX80CM PRODUCT. THEREFORE, IT IS UNLIKELY THAT THE CUSTOMER COULD HAVE CAUSED THE MIX-UP. IN ADDITION, BOTH LOTS INVOLVED WERE BUILT BACK TO BACK ON THE SAME LINE AND BOTH LOTS WERE RE-WORKED ON THE SAME DAY. BASED ON THIS INFORMATION, THE ROOT CAUSE OF THE MISLABELING WAS IDENTIFIED AS A POTENTIAL MANUFACTURING ERROR. A FIELD DISCREPANCY NOTICE WAS ISSUED TO INVESTIGATE HOW THE 5.0X40 AGILTRAC .035 WAS PACKAGED IN A 7.0X20 PACKAGE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: POSSIBLE MISLABELING. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT THERE WAS POSSIBLE MISLABELING ON AN AGILTRAC 35 7X20MM PERIPHERAL DILATATION CATHETER. THE LABELS ON THE OUTER BOX, INNER PLASTIC POUCH, AND INFLATION CARD STATED AGILTRAC 7.0X20. THE DEVICE WAS ADVANCED TO THE LESION IN THE SUPERFICIAL FEMORAL ARTERY; HOWEVER, THE BALLOON WAS VISUALIZED UNDER FLUOROSCOPY AS BEING TOO LONG. THE BALLOON WAS NOT INFLATED AND WAS REMOVED FROM THE BODY WITH NO ADVERSE PATIENT EFFECT. AFTER REMOVAL, THE BALLOON SIDEARM WAS CHECKED AND WAS NOTED AS BEING A 5X40MM SIZE. REPORTEDLY, THE INNER PLASTIC POUCH WAS SEALED BEFORE USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .035 PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7041051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK