BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGICAL BALLOON DILATATION CATHETER

    MDR report key: 2001490 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00370
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE UROMAX ULTRA BALLOON DILATATION CATHETER WAS RETURNED WITHOUT THE BALLOON FOLDED OR WRAPPED AROUND THE CATHETER SHAFT OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION OF THE DEVICE REVEALED NO DAMAGE TO THE SHAFT. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATOR AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) WHEN A LEAK WAS NOTED. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED A PINHOLE 2 MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. NO OTHER DEFECTS WERE NOTED WITH 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A URETERAL DILATATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEFLATED BALLOON WAS INITIALLY PLACED AT THE APPROPRIATE LOCATION IN THE URETER. THE BALLOON WAS INFLATED TO ABOUT THREE TO FOUR ATM WITH A MIXTURE OF 50% SALINE AND 50% CONTRAST, WHEN THE PHYSICIAN NOTICED A POOLING OF CONTRAST IN THE BLADDER. THERE APPEARED TO BE A PARTIALLY CIRCUMFERENTIAL TEAR LOCATED TOWARDS THE DISTAL END OF THE BALLOON. THE BALLOON WAS REMOVED AND NO PIECES DETACHED INSIDE THE PATIENT. THE PATIENT HAD A KIDNEY STONE AND URETERAL STRICTURES, WHICH THE PHYSICIAN LASER TREATED. 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 URETERAL DILATATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEFLATED BALLOON WAS INITIALLY PLACED AT THE APPROPRIATE LOCATION IN THE URETER. THE BALLOON WAS INFLATED TO ABOUT THREE TO FOUR ATM WITH A MIXTURE OF 50% SALINE AND 50% CONTRAST, WHEN THE PHYSICIAN NOTICED A POOLING OF CONTRAST IN THE BLADDER. THERE APPEARED TO BE A PARTIALLY CIRCUMFERENTIAL TEAR LOCATED TOWARDS THE DISTAL END OF THE BALLOON. THE BALLOON WAS REMOVED AND NO PIECES DETACHED INSIDE THE PATIENT. THE PATIENT HAD A KIDNEY STONE AND URETERAL STRICTURES, WHICH THE PHYSICIAN LASER TREATED. 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 M0062251370 0013908229

    Patients

    Seq Age Sex Outcome Treatment
    1