BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI?

    MDR report key: 3233587 · Received July 18, 2013

    Report

    Report Number
    3005099803-2013-06975
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A DETAILED DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED GEMINI BASKET; THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BASKET WIRE(S) BROKE. ALL OF THE BASKET WIRES WERE PRESENT AND ATTACHED. THE OUTER SHEATH WAS TORN AND DETACHED AT THE DISTAL END OF THE BLACK HEATH SHRINK; THE SHEATH REMAINED ON THE WIRE SUB-ASSEMBLY WHEN RECEIVED. THE SHEATH BUCKLED AND KINKED APPROXIMATELY NEAR THE DISTAL TIP. THE BASKET WOULD NOT FUNCTION WHEN ACTUATED DUE TO THE TORN SHEATH. THE WIRE SUB-ASSEMBLY WAS BENT IN SEVERAL LOCATIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE SHEATH DEFECTS AND BENT WIRE SUB-ASSEMBLY IS OPERATIONAL/PHYSIOLOGICAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND THERE WERE NO NON-CONFORMING EVENTS OR ANY DEVIATIONS IDENTIFIED. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS. BASED ON THIS ANALYSIS, THIS EVENT HAS BEEN DEEMED TO NO LONGER BE MDR-REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THREE OF THE BASKET WIRES BROKE OFF DURING THE PROCEDURE AND THERE WERE NO FRAGMENTS THAT FELL INSIDE THE PATIENTS' BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S 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 IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THREE OF THE BASKET WIRES BROKE OFF DURING THE PROCEDURE AND THERE WERE NO FRAGMENTS THAT FELL INSIDE THE PATIENTS' BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332989 GEMINI? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063303060 16059937

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR