BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGURA HEMISPHERE STONE RETRIEVAL BASKET

    MDR report key: 1972488 · Received January 28, 2011

    Report

    Report Number
    3005099803-2011-00132
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    K935726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    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. BASED ON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE OUTER SHEATH WAS TORN ON THE DISTAL END AND A FRAGMENT OF THE DISTAL END WAS DETACHED, WHICH PREVENTED THE BASKET FROM CLOSING. THE OUTER SHEATH AND DRIVE WIRE WERE KINKED, AND THE BASKET WAS BENT. THE OUTER SHEATH WAS MOST LIKELY TORN OFF BY INTERACTION WITH A SHARPER OBJECT DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS USED IN A STONE EXTRACTION PROCEDURE ON A (B)(6) OLD, MALE PATIENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, APPROXIMATELY 1/2-INCH OF THE DISTAL TIP DETACHED IN THE PATIENT'S URETER. THE FRAGMENT WAS RETRIEVED USING TRICEP FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN UNKNOWN BASKET. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS USED IN A STONE EXTRACTION PROCEDURE ON A (B)(6), MALE PATIENT.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, APPROXIMATELY 1/2-INCH OF THE DISTAL TIP DETACHED IN THE PATIENT'S URETER. THE FRAGMENT WAS RETRIEVED USING TRICEP FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN UNKNOWN BASKET. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

    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 M0063801120 13830180

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention