BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1170228 · Received September 11, 2008

    Report

    Report Number
    1219856-2008-00432
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE BALLOON WAS PREPPED, THEN INSERTED INTO THE SHEATH. HOWEVER, THE BALLOON BECAME STUCK INSIDE THE SHEATH AND AS A RESULT, BOTH CATHETER AND SHEATH WERE EXCHANGED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC MF8061413

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN