BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 3180130 · Received June 13, 2013

    Report

    Report Number
    1219856-2013-00142
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CATH LAB DURING USE AND THE PATIENT WAS RECEIVING RESUSCITATION. THE INTRA-AORTIC BALLOON (IAB) WAS PREPARED AS PER PROTOCOL. THE DOCTOR ATTEMPTED TO INSERT THE IAB THROUGH THE SHEATH VIA RIGHT FEMORAL ARTERY, BUT EXPERIENCED DIFFICULTY IN PASSING THROUGH THE SHEATH AND MET SOME RESISTANCE. BLOOD WAS OBSERVED IN THE IAB GAS LUMEN. AS A RESULT, THE IAB AND SHEATH WERE REMOVED AS ONE UNIT SUCCESSFULLY, A NEW IAB WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND INSERTED OVER THE ORIGINAL SPRING WIRE GUIDE AND INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT WAS INITIATED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY JUST LONG ENOUGH TO PREP AND INSERT A NEW IAB WITH NO HARM TO THE PATIENT. THE DOCTOR REPORTED NO DEATH, COMPLICATIONS OR INJURY. THE PATIENT OUTCOME IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 STATED THE PATIENT OUTCOME WAS THE PATIENT SURVIVED AND WAS SUCCESSFULLY RESUSCITATED. THEY WERE ABLE TO PROVIDE IABP THERAPY SUCCESSFULLY AS PLANNED WITH THE SECOND IAB. THE PUMP WAS NOT CHECKED OUT DUE TO PUMPING WAS NOT INITIATED YET AS THE BLOOD WAS NOTED ON INSERTION. THE SHEATH USED WAS THE HEMOSTATIS SHEATH INTRODUCER WITH SIDEARM AND DILATOR ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268654 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC KF2083960

    Patients

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