BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 1873388 · Received September 20, 2010

    Report

    Report Number
    1219856-2010-00627
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 13, 2010
    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

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE TEFLON SHEATH WAS INSERTED INTO THE PT'S FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO THE TEFLON SHEATH AND THE "BALLOON WAS UNWRAPPED." AS A RESULT, THE IAB COULD NOT BE ADVANCED IN THE SHEATH. THE MD REMOVED THE IAB AND A NEW KIT WAS USED. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. IT IS UNK IF THERE WAS A DELAY IN THERAPY. THE PT OUTCOME IS LISTED AS "GOOD." ADDITIONAL INFO RECEIVED ON 09/10/2010 FROM ARROW JAPAN STATED THAT THE IAB WAS PREPPED PER INSTRUCTION. THE IAB WAS REMOVED AND SHEATH REMAINED IN INSERTION SITE. A NEW IAB WAS INSERTED INTO THE SHEATH SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC. MF9056685

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN