BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1685976 · Received May 13, 2010

    Report

    Report Number
    3005099803-2010-02142
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Report Date
    April 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THE DEVICE POUCH SEAL BROKEN. THE TORN POUCH APPEARED TO HAVE BEEN CAUSED BY PRESSURE APPLIED TO THE SEAL. THE TORN EDGE OF THE POUCH WAS FRAYED, AND IT APPEARED AN ATTEMPT WAS BEING MADE TO OPEN THE POUCH. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS HANDLING DAMAGE.

    Additional Manufacturer Narrative · 1

    ALTHOUGH EXPECTED, THE DEVICE AT ISSUE IN THIS COMPLAINT HAS NOT YET BEEN RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THERE WAS NO PROCEDURE INVOLVED. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DAMAGE WAS NOTICED ON A ZERO TIP NITINOL STONE RETRIEVAL BASKET DURING UNPACKING. ACCORDING TO THE COMPLAINANT, A HOLE WAS OBSERVED ON THE PACKAGE OF THE RETRIEVAL DEVICE. NO DAMAGE TO THE OUTER BOX WAS NOTICED.

    Description of Event or Problem · 1

    NOTE: THERE WAS NO PROCEDURE INVOLVED. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DAMAGE WAS NOTICED ON A ZERO TIP NITINOL STONE RETRIEVAL BASKET DURING UNPACKING. ACCORDING TO THE COMPLAINANT, A HOLE WAS OBSERVED ON THE PACKAGE OF THE RETRIEVAL DEVICE. NO DAMAGE TO THE OUTER BOX WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063901050 13130943

    Patients

    Seq Age Sex Outcome Treatment
    1