BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI¿

    MDR report key: 3112368 · Received May 14, 2013

    Report

    Report Number
    3005099803-2013-03477
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT WAS PERFORMED ON THE RETURNED GEMINI RETRIEVAL BASKET. THE BASKET WAS CLOSED WHEN RECEIVED. THE SHEATH WAS BUCKLED AND TORN NEAR THE DISTAL END OF THE BLACK STRAIN RELIEF. A FUNCTIONAL EVALUATION WAS PERFORMED. WHEN THE HANDLE WAS ACTUATED, THE BASKET WOULD NOT OPEN. THE WIRE SUB ASSEMBLY WAS KINKED AT THE DISTAL END OF THE HANDLE CANNULA. THE BASKET WIRES WERE ALL PRESENT AND ATTACHED; THE BASKET WIRES WERE KINKED/BENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED WHICH REVEALED NO ISSUES RELATED TO THE COMPLAINT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI RETRIEVAL BASKET WAS USED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH BECAME DETACHED FROM THE HANDLE CAUSING THE BASKET NOT TO OPEN AND CLOSE. THE DEVICE DID NOT DETACH INSIDE THE PATIENT. IT WAS REPORTED THAT THERE WAS A STONE IN THE BASKET AT THE TIME OF THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER GEMINI RETRIEVAL BASKET. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212280 GEMINI¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC M0063303040 15526593

    Patients

    Seq Age Sex Outcome Treatment
    1