BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 4 FR 5 0CM

    MDR report key: 1881851 · Received October 8, 2010

    Report

    Report Number
    2242445-2010-00064
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FIELD IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE MD INSERTED THE AI-07-134, INSERTION SITE IS UNKNOWN. AFTER THE AI-07-134 WAS INSERTED, THE MD TRIED TO INFLATE THE BALLOON BY INJECTING CO2. THE CONTRAST AGENT ENTERED THE BALLOON AND AS A RESULT, THE MD REMOVED THE CATHETER AND INSERTED A NEW CATHETER. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2010 FROM ARROW (B)(6) STATED THAT; "WHEN THE CONTRAST AGENT WAS INJECTED AT 600PSI FOR THE FIRST TIME, THE AGENT CAME OUT OF THE BALLOON LUMEN, WHICH WAS SHOWN IN THE X-RAY. BOTH FLUSHING OF THE CATHETER AND INFLATION TEST WERE DONE, BUT IT IS UNKNOWN WHICH WAS DONE FIRST." THERE WAS NO REPORTED PATIENT DEATH OR INJURY. IT IS UNKNOWN IF THERE WAS A DELAY IN THERAPY. THE OUTCOME OF THE PATIENT IS LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: BERMAN 4 FR 5 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC. MF0021420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK