BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1881852 · Received October 8, 2010

    Report

    Report Number
    1219856-2010-00725
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOS
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    REFERENCE MDR #1219856-2010-00724 FOR FIRST EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED A MALE BORN IN 1934 WITH THE DIAGNOSIS OF CARDIOGENIC SHOCK WAS IN THE CATH LAB. THE INTRA-AORTIC BALLOON (IAB) FIBEROPTIX SENSOR (FOS) WAS NOT DETECTED DURING ZEROING. THE PHYSICIAN PREPPED A THIRD IAB WELL AND INSERTED IT WITHOUT DIFFICULTY OVER THE SPRING WIRE GUIDE (SWG), WHICH WAS INTACT FROM THE FIRST ATTEMPT. THERE WAS NO PATIENT DETACH, INJURIES OR COMPLICATIONS NOTED. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME IS LISTED AS "OK" AFTER THE PROCEDURE. THE PATIENT DIED TO CARDIOGENIC SHOCK DESPITE USE OF CATECHOLAMINES ON (B)(6) 2010 PER THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) FOS ARROW INTERNATIONAL INC. MF0073855

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR INTRA-AORTIC BALLOON PUMP| CATECHOLAMINES