BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DIVERSION STENT

    MDR report key: 2130176 · Received June 16, 2011

    Report

    Report Number
    3005099803-2011-02043
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LJE
    PMA / PMN Number
    K830803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PERCUFLEX URETERAL STENT REVEALED THAT THE POUCH WAS NOT PROPERLY SEALED DURING THE MANUFACTURING PRODUCT PACKAGING PROCESS. THERE IS NO EVIDENCE TO INDICATE THE STENT POUCH WAS SEALED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT UPON UNPACKING A PERCUFLEX URINARY DIVERSION STENT INTENDED TO BE PLACED IN THE PATIENT, IT WAS DISCOVERED THAT ONE OF THE STERILE BAGS HAD ALREADY BEEN OPENED; IT WAS NOT SEALED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PERCUFLEX URINARY DIVERSION STENT, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "GOOD." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT UPON UNPACKING A PERCUFLEX URINARY DIVERSION STENT INTENDED TO BE PLACED IN THE PATIENT, IT WAS DISCOVERED THAT ONE OF THE STERILE BAGS HAD ALREADY BEEN OPENED; IT WAS NOT SEALED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PERCUFLEX URINARY DIVERSION STENT, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "GOOD." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINARY DIVERSION STENT CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC - SPENCER M0061602100 12109931

    Patients

    Seq Age Sex Outcome Treatment
    1