BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA¿

    MDR report key: 2231653 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02863
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE CATHETER SHAFT WAS STRETCHED FOR 42 MM AT 325 MM PROXIMAL TO THE DISTAL TIP. A FUNCTIONAL ANALYSIS REVEALED THAT THE BALLOON COULD NOT BE INFLATED TO ITS RATED BURST PRESSURE (RBP) DUE TO A PINHOLE LOCATED AT THE DISTAL TRANSITION ZONE. OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON DILATATION CATHETER WAS USED DURING A CYSTOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON LEAKED FROM A PINHOLE WHEN IT WAS INFLATED TO BETWEEN 8-10 ATM. THE BALLOON WAS INFLATED WITH WATER AND THE LEAKAGE WAS NOTICED WHEN THE BALLOON FAILED TO INCREASE IN PRESSURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UROMAX ULTRA BALLOON WITH NO COMPLICATIONS. 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 CYSTOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON LEAKED FROM A PINHOLE WHEN IT WAS INFLATED TO BETWEEN 8-10 ATM. THE BALLOON WAS INFLATED WITH WATER AND THE LEAKAGE WAS NOTICED WHEN THE BALLOON FAILED TO INCREASE IN PRESSURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UROMAX ULTRA BALLOON WITH NO COMPLICATIONS. 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 UROMAX ULTRA¿ DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251050 0014123303

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR