BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RE-ENTRY? MALECOT NEPHROSTOMY CATHETER SET

    MDR report key: 4259325 · Received November 18, 2014

    Report

    Report Number
    3005099803-2014-03696
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GBO
    PMA / PMN Number
    K820867
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED RE-ENTRY MALECOT NEPHROSTOMY CATHETER SET REVEALED THAT THE CATHETER AND THE GREEN DISTAL TIP WERE KINKED IN SEVERAL LOCATIONS THE CATHETER WAS BROKEN NEAR THE LOCATION OF THE CATHETER SHAFT BOND. THE BROKEN ENDS WERE NOT STRAIGHT AND WERE NOT PERPENDICULAR WITH THE SIDES OF THE CATHETER. A BLUE RESIDUE WAS PRESENT NEAR THE BREAK ON BOTH SIDES. EXAMINATIONS OF THE BONDED ENDS UNDER MAGNIFICATION DEMONSTRATE THE BOND WAS MADE DURING MANUFACTURING. A SUTURE WAS WRAPPED AROUND THE CATHETER APPROXIMATELY 7.5CM FROM THE DISTAL END OF THE PROXIMAL FRAGMENT. THE SUTURE APPEARED TO HAVE BEEN USED TO PULL THE DEVICE AS THE SUTURE WAS CINCHED INTO THE CATHETER. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RE-ENTRY MALECOT NEPHROSTOMY CATHETER SET WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, UPON REMOVAL OF THE RE-ENTRY MALECOT DRAINAGE NEPHROSTOMY CATHETER THE MIDDLE PART DETACHED INSIDE THE PATIENT. THE DETACHED PART WAS SUCCESSFULLY RETRIEVED WITH A PLIER. THE PATIENT 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 RE-ENTRY MALECOT NEPHROSTOMY CATHETER SET WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, UPON REMOVAL OF THE RE-ENTRY MALECOT DRAINAGE NEPHROSTOMY CATHETER THE MIDDLE PART DETACHED INSIDE THE PATIENT. THE DETACHED PART WAS SUCCESSFULLY RETRIEVED WITH A PLIER. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744632 RE-ENTRY? MALECOT NEPHROSTOMY CATHETER SET CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO BOSTON SCIENTIFIC - SPENCER M0064101040

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention