BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 3032942 · Received April 1, 2013

    Report

    Report Number
    1219856-2013-00081
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CARDIO CATH LAB DURING INSERTION. THE MD FOLLOWED THE INSTRUCTIONS FOR USE (IFU) EXACTLY BEFORE THE INTRA-AORTIC BALLOON (IAB) INSERTION. THE MD VACUUMED THE IAB PROPERLY INSIDE OF THE TRAY. AFTER THE MD INSERTED THE IAB VIA LEFT FEMORAL ARTERY WITH NO ISSUES, THE MD OPERATED THE INTRA-AORTIC BALLOON PUMP (IABP), BUT THE DEVICE DID NOT WORK; THE IAB WOULD NOT INFLATE AND DEFLATE. AS A RESULT, THE MD TURNED THE PUMP OFF AND REMOVED THE IAB SUCCESSFULLY. THE MD REPLACED THE KIT AND INSERTED THE SECOND IAB VIA THE SAME INSERTION SITE SUCCESSFULLY AND THE PROCEDURE WENT ON AS PLANNED. THERE WAS NO REPORT OF PATIENT DEATH OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A FEW MINUTES DELAY OR INTERRUPTION IN THERAPY NOTED. THE PATIENT OUTCOME IS THE PROCEDURE WAS WELL PERFORMED WITH NO COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 STATED THE IAB WAS NOT INFLATING UNDER FLUOROSCOPY; THE PUMP DID ALARM. THE MD COULD NOT REMEMBER WHAT THE PUMP ALARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132551 IAB: 8 FR - 40 CC INTRA-AORTIC BALLON PRODUCTS DSP ARROW INTL., INC. KF2022501

    Patients

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