BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT

    MDR report key: 3243061 · Received July 18, 2013

    Report

    Report Number
    1018233-2013-02912
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 10, 2013
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K983498
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED WITH CAUSE UNK. THE RETURNED STENT WAS BROKEN FROM ONE OF THE PIGTAILS. THERE WAS NO SUTURE OR PIGTAIL RETURNED FOR EVAL. THE PACKAGE WAS RECEIVED OPENED AND THE INTERNAL UNIT PACKAGING (PLASTIC BAG) WAS OPENED. THE BREAKAGE SITE PRESENTS JAGGED EDGES AND STRESS MARKS AS INDICATIVE THAT THE STENT HAS BEEN STRESSED BEYOND ITS TENSILE CAPABILITIES. THE BROKEN SECTION IS LOCATED AT ONE OF THE HOLES/PERFORATIONS OF PIGTAIL STENT. THE LENGTH OF STENT IS 10.500". DIMENSIONAL EVAL REVEALED THAT THE STENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. AN ENTIRE REVIEW OF DEVICE HISTORY RECORDS WAS DONE FOR THE INVOLVED LOT AND NO DISCREPANCIES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE WERE NO DOCUMENTED INTERNAL REJECTS RELATED TO THE REPORTED ISSUE DURING THE MANUFACTURING OF THE REPORTED PRODUCTION BATCH. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: IMPROPER HANDLING TECHNIQUE CAN SERIOUSLY WEAKEN THE STENT. ACUTE BENDING OR OVERSTRESSING DURING PLACEMENT COULD RESULT IN SUBSEQUENT SEPARATION OF THE STENT AT THE POINT OF STRESS AFTER A PROLONGED INDWELLING PERIOD. SUTURE MAY BE CUT OFF PRIOR TO STENT PLACEMENT. REMOVE SUTURE PRIOR TO PLACEMENT FOR PEDIATRIC PTS. EXERCISE CARE. TEARING OF THE STENT CAN BE CAUSED BY SHARP INSTRUMENTS. CARE SHOULD BE EXERCISED WHEN REMOVING STENT FROM INNER POLYBAG SO AS NOT TO CAUSE TEARING OR FRAGMENTATION. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT ONE EXTREMITY OF THIS DOUBLE PIGTAIL URETERAL STENT PRESENTED DEFECT. PER ADDITIONAL INFORMATION RECEIVED, THE PIGTAIL END OF THE STENT WAS MISSING AND NO BROKEN PIECES WERE FOUND IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335311 BARD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT FAD PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGWJ1768

    Patients

    Seq Age Sex Outcome Treatment
    1