BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA HEMISPHERE?

    MDR report key: 3133667 · Received May 29, 2013

    Report

    Report Number
    3005099803-2013-04162
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    K935725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 VISUAL ASSESSMENT WAS PERFORMED AND REVEALED THAT THE DISTAL END OF THE SHEATH WAS SPLIT FOR APPROXIMATELY 1.2CM. THE BASKET EXTENDED FROM THE DISTAL END OF THE SHEATH APPROXIMATELY 1.2CM WHEN RECEIVED. A TORQUE MARK WAS PRESENT ON THE HANDLE CAP TO INDICATE THE CAP WAS PROPERLY TORQUED DURING MANUFACTURING. THE HANDLE CANNULA WAS VISIBLE THROUGH THE HANDLE. A FUNCTIONAL EVALUATION WAS PERFORMED AND WHEN THE HANDLE WAS ACTUATED THE BASKET WOULD FUNCTION. THE BASKET WOULD NOT CLOSE INTO THE SHEATH DUE TO THE SPLIT. ALL OF THE BASKET WIRES WERE PRESENT AND ATTACHED; HOWEVER, TWO OF THE BASKET WIRES WERE BENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR DEVICE FUNCTIONALITY/INTEGRITY. THE DEFECTS IDENTIFIED ON THE DEVICE WERE MOST LIKELY DUE TO SOME OPERATIONAL OR ANATOMICAL ASPECT ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT. 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 SEGURA HEMISPHERE RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE SHEATH AROUND THE BASKET SPLIT AFTER RETRIEVAL AND THE BASKET APPEARED TO BE BROKEN. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE SHEATH AROUND THE BASKET SPLIT AFTER RETRIEVAL AND THE BASKET APPEARED TO BE BROKEN. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237566 SEGURA HEMISPHERE? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063801100 15869512

    Patients

    Seq Age Sex Outcome Treatment
    1