BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGICAL BALLOON DILATATION CATHETER

    MDR report key: 2040249 · Received April 5, 2011

    Report

    Report Number
    3005099803-2011-00985
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT. A VISUAL AND TACTILE EXAMINATION OF THE RETURNED UROMAX ULTRA BALLOON DILATATION CATHETER REVEALED A KINK ON THE BALLOON CATHETER AT THE BASE OF THE STRAIN RELIEF. THE BALLOON WAS NOT FOLDED OR WRAPPED AROUND THE SHAFT OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATOR AND THE INFLATED TO ITS RATED BURST PRESSURE WITH NO LEAKS NOTED. A VACUUM WAS APPLIED AND THE BALLOON DEFLATED WITH NO ISSUES NOTED. NO OTHER DEFECTS WERE NOTED WITH THE DEVICE. THE DEVICE EVALUATION DID NOT CONFIRM THE REPORTED EVENT. THE MOST PROBABLE ROOT CAUSE FOR THE EVENT WAS DETERMINED TO BE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE BALLOON BURST AT 12 ATM INSIDE THE PATIENT DURING THE PROCEDURE. THE BALLOON STAYED INTACT. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE BALLOON BURST AT 12 ATM INSIDE THE PATIENT DURING THE PROCEDURE. THE BALLOON STAYED INTACT. 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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROLOGICAL BALLOON DILATATION CATHETER DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251220 14024865

    Patients

    Seq Age Sex Outcome Treatment
    1