BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA¿

    MDR report key: 6195856 · Received December 21, 2016

    Report

    Report Number
    3005099803-2016-03958
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: VISUAL EXAMINATION OF THE RETURNED UROMAX ULTRA BALLOON CATHETER IDENTIFIED NO DAMAGE TO THE TIP SECTION OF THE DEVICE. VISUAL AND TACTILE EXAMINATION FOUND A KINK IN THE SHAFT AT 14.1CM DISTAL TO THE STRAIN RELIEF. THIS KINK WAS CONSISTENT WITH EXCESSIVE FORCE APPLIED TO THE SHAFT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED UROMAX ULTRA BALLOON CATHETER IDENTIFIED NO DAMAGE TO THE TIP SECTION OF THE DEVICE. VISUAL AND TACTILE EXAMINATION FOUND A KINK IN THE SHAFT AT 35.6CM DISTAL TO THE STRAIN RELIEF WHICH IS CONSISTENT WITH EXCESSIVE FORCE HAVING APPLIED TO THE SHAFT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX BALLOON CATHETER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER OF THE DEVICE WAS FOUND BENT; HENCE, THE GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX BALLOON CATHETER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER OF THE DEVICE WAS FOUND BENT; HENCE, THE GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX BALLOON CATHETER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER OF THE DEVICE WAS FOUND BENT; HENCE, THE GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845606 UROMAX ULTRA¿ DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251200 19240861

    Patients

    Seq Age Sex Outcome Treatment
    1