BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 2072847 · Received April 29, 2011

    Report

    Report Number
    2134265-2011-01411
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLY ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS ABDOMINAL ARTERY. THE (B)(4) EQUALIZER BALLOON CATHETER WAS SELECTED TO POST-DILATE A WALLSTENT. INFLATION WAS PERFORMED TWICE AND UPON THE SECOND INFLATION THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS CONTINUED WITH ANOTHER EQUALIZER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER BALLOON CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M001171070 13558987

    Patients

    Seq Age Sex Outcome Treatment
    1 WALLSTENT