BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI STONE RETRVL PAIRED WIRE HELICAL BSKT

    MDR report key: 2111091 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01828
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET REVEALED THE DEVICE BASKET WAS DETACHED. THE WIRE SUBASSEMBLY (S/A) DETACHED IN THE MIDDLE OF THE SPLICE CANNULA. THE BASKET WAS BENT. THE WIRE S/A WAS BENT ON THE DISTAL END OF THE BROKEN SPLICE CANNULA. THE OUTER SHEATH WAS KINKED AND BENT. OTHER DEFECTS ON THE DEVICE (BENT BASKET, BENT WIRE S/A, AND KINKED/BENT OUTER SHEATH) INDICATE SIGNIFICANT FORCES WERE APPLIED. IT WAS NOT POSSIBLE TO DETERMINE THE AMOUNT OF FORCE THAT WAS EXERTED ON THE WIRE S/A TO CAUSE IT TO BREAK. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE UNDETERMINABLE. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE ACCEPTED DEVICES MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET WAS USED IN AN URETEROSCOPY STONE RETRIEVAL PROCEDURE ON A PATIENT (WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BASKET SNAPPED OFF THE DISTAL MANDREL INSIDE THE PATIENT AFTER DURING IT WAS PLACED IN THE PATIENT'S LEFT URETER. THE BASKET WAS RETRIEVED USING GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND AGEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET WITHOUT COMPLICATIONS. THE PATIENT IS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET WAS USED IN AN URETEROSCOPY STONE RETRIEVAL PROCEDURE ON A PATIENT (WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BASKET SNAPPED OFF THE DISTAL MANDREL INSIDE THE PATIENT AFTER DURING IT WAS PLACED IN THE PATIENT'S LEFT URETER. THE BASKET WAS RETRIEVED USING GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND AGEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET WITHOUT COMPLICATIONS. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI STONE RETRVL PAIRED WIRE HELICAL BSKT DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063301060 14009473

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention