BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGICAL BALLOON DILATATION CATHETER

    MDR report key: 2003977 · Received March 1, 2011

    Report

    Report Number
    3005099803-2011-00456
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT. THE UROMAX ULTRA BALLOON DILATATION CATHETER WAS RETURNED WITHOUT THE BALLOON FOLDED OR WRAPPED AROUND THE CATHETER SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE DEVICE REVEALED A KINK 120 MM DISTAL TO THE STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL 29 MM IN LENGTH, STARTING 25 MM PROXIMAL TO THE TIP OF THE DEVICE AND EXTENDING PROXIMALLY. NO OTHER DEFECTS WERE NOTED TO THE DEVICE. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS DETERMINED TO BE OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, THE BALLOON BROKE INSIDE THE URETER, BUT DID NOT FRAGMENT. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT WITH ALL PARTS OF THE DEVICE INTACT, BUT THE BALLOON MATERIAL WAS TORN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE DILATING THE BALLOON WITHIN THE PATIENT'S URETER, THE BALLOON BROKE INTO SEVERAL FRAGMENTS. ALL FRAGMENTS WERE REMOVED. IT IS UNKNOWN WITH WHAT DEVICE THE BALLOON WAS INFLATED. IT IS ALSO UNKNOWN HOW THE BALLOON FRAGMENTS WERE REMOVED. IT WAS REPORTED THAT THERE WERE NO OTHER PATIENT COMPLICATIONS. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UROMAX ULTRA BALLOON DILATATION CATHETER AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAM, RIGHT URETERAL BALLOON DILATATION, BILATERAL URETEROSCOPY, AND PLACEMENT OF A RIGHT URETERAL STENT. IT WAS ALSO REPORTED THAT THERE WERE NO KIDNEY STONES PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROLOGICAL BALLOON DILATATION CATHETER DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251210 13916301

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR