BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERAL CATHETER

    MDR report key: 3904472 · Received July 1, 2014

    Report

    Report Number
    3005099803-2014-02414
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GBM
    PMA / PMN Number
    K830840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT ON THE RETURNED URETERAL CATHETER WAS PERFORMED AND IT WAS NOTED THAT RESIDUE IS PRESENT. THERE WAS A SPOT WHERE THE OUTER DIAMETER WAS SMALLER ON THE PROXIMAL END WHERE THE CONNECTOR HAD BEEN TIGHTENED DOWN, HOWEVER, THE CONNECTOR WAS NOT RETURNED. THE CATHETER WAS BROKEN INTO TWO FRAGMENTS. THE DISTAL FRAGMENT MEASURED APPROXIMATELY 41.2CM, AND THE PROXIMAL END MEASURED APPROXIMATELY 27.6CM LONG. THE BROKEN ENDS APPEARED TO BE CUT AS THE BREAK IS CLEAN AND HAS NO SIGNS OF STRETCHING. THE BROKEN ENDS DO NOT MATCH AS THE CUT WAS PARTIALLY INTO THE PAINT BAND ON ONE END, AND THE OTHER HAS NO SIGN OF PAINT. WHEN THE TWO LENGTHS ARE ADDED TOGETHER, THE TOTAL LENGTH IS APPROXIMATELY 68.8CM, WHICH IS BELOW THE SPECIFICATION. THE CATHETER WAS BENT IN SEVERAL LOCATIONS. A 0.038¿ GUIDEWIRE WAS INSERTED INTO BOTH FRAGMENTS AND IT PASSED FREELY. THE MATERIAL WAS FLEXED AND DID NOT APPEAR TO BE BRITTLE SINCE IT DID NOT BREAK. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THEREFORE, TAKING INTO CONSIDERATION THESE FACTORS AND THE ANALYSIS PERFORMED IN THE RETURNED DEVICE, THE MOST PROBABLE ROOT CAUSE IS "UNDETERMINABLE."

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS UNDER THE AGE OF 18. REPORTED EVENT OF CATHETER BROKEN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 URETERAL CATHETER WAS USED DURING A CYSTO, LEFT URETEROSCOPY WITH LASER AND STENT PLACEMENT PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE URETERAL CATHETER THAT THEY WERE USING BROKE IN HALF. IT WAS UNKNOWN IF THE PROBLEM OCCURRED INSIDE OR OUTSIDE THE PATIENT AND HOW WAS THE PROCEDURE COMPLETED. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A URETERAL CATHETER WAS USED DURING A CYSTO, LEFT URETEROSCOPY WITH LASER AND STENT PLACEMENT PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE URETERAL CATHETER THAT THEY WERE USING BROKE IN HALF. IT WAS UNKNOWN IF THE PROBLEM OCCURRED INSIDE OR OUTSIDE THE PATIENT AND HOW WAS THE PROCEDURE COMPLETED. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384546 URETERAL CATHETER CATHETER, URETHRAL GBM BOSTON SCIENTIFIC - SPENCER M0064002011 16670944

    Patients

    Seq Age Sex Outcome Treatment
    1