BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI?

    MDR report key: 3233625 · Received July 18, 2013

    Report

    Report Number
    3005099803-2013-06441
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DETAILED DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED GEMINI BASKET AND REVEALED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BASKET WAS DETACHED. THE BASKET WAS NO LONGER PRESENT WHEN RETURNED AND THE WIRE DETACHED AT THE SPLICE CANNULA. THE OUTER SHEATH WAS KINKED NEAR THE DISTAL END. THE BROKEN WIRE SUB-ASSEMBLY MOVE FREELY THROUGH THE SHEATH WHEN THE HANDLE WAS ACTUATED. THE WIRE SUB-ASSEMBLY SPLICE JOINTS ARE 100% INSPECTED IN PROCESS PER THE SOLDER SPLICE AND GRIND GOI. OTHER DEFECTS THAT WERE IDENTIFIED INDICATE THAT SIGNIFICANT FORCES WERE APPLIED. THE AMOUNT OF FORCE EXERTED ON THE WIRE SUB-ASSEMBLY CAUSING IT TO BREAK WAS IMPOSSIBLE TO DETERMINE. THE DEFECT COULD BE RELATED TO MANUFACTURING, USE, OPERATIONAL CONTEXT, OR POSSIBLY INTERACTION WITH THE SCOPE OR ANOTHER DEVICE DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE DETACHED BASKET IS UNDETERMINABLE. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT; THERE WERE NO NON-CONFORMING EVENTS OR ANY DEVIATIONS IDENTIFIED. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6), 2013.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET DETACHED INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED BASKET BUT WAS UNSUSCCESFUL; HOWEVER THE PHYSICIAN WAS ABLE TO REMOVE THE STONES WITH THE USE OF A RETRIEVAL GRASPER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE DETACHED BASKET WAS SUCCESSFULLY REMOVED ON (B)(6), 2013 VIA A PERCUTANEOUS ACCESS PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET DETACHED INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED BASKET BUT WAS UNSUCCESSFUL; HOWEVER THE PHYSICIAN WAS ABLE TO REMOVE THE STONES WITH THE USE OF A RETRIEVAL GRASPER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE DETACHED BASKET WAS SUCCESSFULLY REMOVED ON (B)(6) 2013 VIA A PERCUTANEOUS ACCESS PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335886 GEMINI? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063301090 16110011

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention