BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 2080109 · Received April 7, 2011

    Report

    Report Number
    1219856-2011-00125
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT IN THE CARDIAC CATH LAB. THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE SHEATH WAS INSERTED INTO THE PTS' FEMORAL ARTERY. THE MD COULD NOT ADVANCE THE IAB THROUGH THE SHEATH. AS A RESULT, THE MD REMOVED THE IAB FROM THE SHEATH AND REQUESTED ANOTHER IAB FOR INSERTION. THE SECOND IAB WAS PREPPED AND INSERTED THROUGH THE EXISTING SHEATH WITHOUT DIFFICULTY. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. IAB THERAPY WAS DELAYED FOR THE AMOUNT OF TIME TAKEN TO PREP AND INSERT THE SECOND IAB. THE PT RECEIVED INTRA-AORTIC BALLOON PUMP (IABP) THERAPY SUCCESSFULLY. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT OUTCOME IS LISTED AS OK.

    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 KF0118557

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP