BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA HEMISPHERE STONE RETRIEVAL BASKET

    MDR report key: 1910570 · Received November 30, 2010

    Report

    Report Number
    3005099803-2010-04965
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    K935721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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. A FUNCTIONAL EVALUATION WAS PERFORMED, AND IT WAS OBSERVED THAT WHEN THE HANDLE WAS ACTUATED, THE BASKET WOULD NOT MOVE. THE HANDLE CANNULA WAS DETACHED FROM THE PINCH VISE. THE FORCES ENCOUNTERED WHILE UNPACKING THE DEVICE, WHILE HANDLING PRIOR TO USE, OR DURING USE IN THE PROCEDURE MOST LIKELY CAUSED THE HANDLE CANNULA TO BE PULLED OUT OF THE PINCH VISE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT ID, AGE, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BASKET WOULD NOT OPEN AND CLOSE. IT IS UNKNOWN IF A STONE WAS IN THE DEVICE WHEN THE MALFUNCTION OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SEGURA HEMISPHERE STONE RETRIEVAL BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT ID, AGE, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BASKET WOULD NOT OPEN AND CLOSE. IT IS UNKNOWN IF A STONE WAS IN THE DEVICE WHEN THE MALFUNCTION OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SEGURA HEMISPHERE STONE RETRIEVAL BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGURA HEMISPHERE STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063801000 13729193

    Patients

    Seq Age Sex Outcome Treatment
    1