BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERAL CATHETER

    MDR report key: 3220816 · Received July 11, 2013

    Report

    Report Number
    3005099803-2013-06492
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GBM
    PMA / PMN Number
    K830840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS NOT UNDER 18.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER'S OCCUPATION IS PHYSICIAN. A VISUAL EXAMINATION OF THE RETURNED DEVICE WAS PERFORMED. THE TIP PROTECTOR WAS RETURNED, BUT NOT ATTACHED TO THE DEVICE WHEN RECEIVED. THE CONNECTOR CAP AND LUER WERE NOT RETURNED. A FUNCTIONAL EVALUATION WAS ALSO PERFORMED. FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CATHETER AND TUBE PROTECTOR WERE KINKED IN THE MIDDLE OF THE WORKING LENGTH; THE CATHETER WAS BENT APPROXIMATELY 2CM FROM THE DISTAL END OF THE CONNECTOR CAP. THE SKIVE HOLE APPEARED TO BE MISSHAPED DUE TO THE KINK. MOST LIKELY, THE KINKS WERE DUE TO SOME ASPECT OF HANDING THE DEVICE PRIOR TO USE IN THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE KINKED CATHETER IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND REVEALED AND THERE WERE NO NON-CONFORMING EVENTS OR ANY DEVIATIONS IDENTIFIED IN THE DHR REVIEW. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS. BASED ON THIS ANALYSIS, THIS EVENT HAS BEEN DEEMED NO LONGER MDR-REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A URETERAL CATHETER WAS USED DURING A CYSTO RETROGRADE PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN NOTICED THAT THE WHISTLE TIP CATHETER WAS VERY SHARP. ANOTHER CATHETER WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE CASE WAS COMPLETED WITH NO ISSUES. 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 RETROGRADE PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN NOTICED THAT THE WHISTLE TIP CATHETER WAS VERY SHARP. ANOTHER CATHETER WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE CASE WAS COMPLETED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321340 URETERAL CATHETER CATHETER, URETHRAL GBM BOSTON SCIENTIFIC - SPENCER M0064002211 16017458

    Patients

    Seq Age Sex Outcome Treatment
    1