BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERAL CATHETER

    MDR report key: 2925013 · Received January 22, 2013

    Report

    Report Number
    3005099803-2012-06444
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    November 5, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOD
    PMA / PMN Number
    K820868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PLEASE NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES. REF: #3005099803-2012-06041. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 6 FR OPEN ENDED URETERAL CATHETER WAS USED DURING A PROCEDURE PRIOR TO COLON RESECTIONS FOR SEVERE DIVERTICULITIS ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, URETERAL STENTS WERE PLACED UNEVENTFULLY AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY URETERAL INJURY AND THE STENTS WERE REMOVED AT THE END OF THE CASE. THE GENERAL SURGEON NOTED SOME MILD HEMATURIA AT THE TIME BUT NOTHING SEVERE OR UNUSUAL. WITHIN EIGHT HOURS, THE PATIENT HAD GROSS HEMATURIA WITH CLOTS AND DEVELOPED ANURIA WITHIN 12-18 HOURS. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) WITHIN EIGHT HOURS FOR THE PLACEMENT OF DOUBLE J STENTS. FOLLOW UP WITH THE COMPLAINANT REVEALED THERE WERE TWO PHYSICIANS AT THIS HOSPITAL WHICH HAD THE REPORTED PROBLEMS OF THE CATHETERS. THERE WAS NOTHING DEFECTIVE OR UNUSUAL ABOUT THE PACKAGING FOR THE URETERAL CATHETERS. THE PROCEDURE WAS UNCOMPLICATED. THE PURPOSE OF THE URETERAL CATHETERS WAS TO FACILITATE URETERAL IDENTIFICATION DURING COMPLEX COLON SURGERY, THEREFORE, BOTH URETERS WERE CATHETERIZED. THERE WAS NEVER A NEED TO USE TWO DIFFERENT CATHETERS ON ONE SIDE. THE URETERAL CATHETERS WERE PLACED UNEVENTFULLY. THE CATHETERS DRAINED FINE DURING THE CASE. BOTH CATHETERS WERE REMOVED AT THE END OF THE GENERAL SURGERY CASE BY THE GENERAL SURGEON ONCE HE WAS SURE HE DID NOT NEED THEM ANYMORE. THERE WAS NOTHING UNUSUAL NOTED AT THE TIME OF CATHETER REMOVAL. THE PROBLEM WAS URETERAL INFLAMMATION AND OBSTRUCTION AFTER THEY WERE REMOVED. THE URETERS SHOWED IRREGULARITY AND NARROWING CONSISTENT WITH EDEMA WITH SOME FILLING DEFECTS FROM CLOTS. WITHIN 12 TO 24 HOURS THE PATIENT HAD GROSS HEMATURIA AND DEVELOPED ANURIA. THE PATIENT RECOVERED COMPLETELY AFTER A TWO TO THREE WEEK INTERVAL OF INDWELLING DOUBLE J STENTS BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30095 URETERAL CATHETER CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC - SPENCER M0064001400 15119124

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention