BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIX ULTRA 8 IAB: 8FR 40CC

    MDR report key: 6138932 · Received December 1, 2016

    Report

    Report Number
    1219856-2016-00265
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SEE ADDITIONAL REPORT MDR# 1219856-2016-00268/ (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: TELEFLEX RECEIVED THE AFFECTED DEVICE FOR ANALYSIS. AN INSPECTION OF THE FIBER OPTIC SENSOR (FOS) CONNECTOR AND CAL KEY WAS COMPLETED. THE GRAY FOS CONNECTER WAS RECEIVED PROPERLY SEATED IN ITS HOUSING. BOTH RETAINING TABS WERE INTACT. THE CENTER POST OF THE FOS WAS CENTERED AND THE BLUE CLAMSHELL HOUSING WAS EXAMINED AND NO DAMAGE WAS NOTED. THE CAL KEY WAS INTACT AND THE CAL KEY AND FOS WERE CONNECTED TO THE IABP AND RECOGNIZED. THE FOS ZEROED PROPERLY AND DISPLAYED AN "OK" STATUS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF UNABLE TO GET FOS SIGNAL IS NOT CONFIRMED. THE FOS WAS ABLE TO ZERO PROPERLY. THE FOS PASSED FUNCTIONAL TESTING. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. OTHER REMARKS: SEE ADDITIONAL REPORT MDR# 1219856-2016-00268/ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A PATIENT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED, AND AFTER THE FIBER OPTIC SENSOR (FOS) KEY WAS INSERTED INTO THE CONSOLE THE FIBER OPTIC SENSOR (FOS) WAS NOT RECOGNIZED. NEVERTHELESS, THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE PATIENTS LEFT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) THERAPY WAS DIFFICULT TO PROVIDE DUE TO NO RECOGNITION OF THE FIBER OPTIC SENSOR (FOS) BY THE CONSOLE AND ANOTHER ERROR MESSAGE. (THE SALES REP WAS UNABLE TO FIND ANYONE WHO RECALLS THE ERROR MESSAGE). THE CARDIOLOGIST DECIDED TO REMOVE THE INTRA-AORTIC BALLOON (IAB) AND REPLACE IT WITH A NEW IAB-05840-LWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A PATIENT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED, AND AFTER THE FIBER OPTIC SENSOR (FOS) KEY WAS INSERTED INTO THE CONSOLE THE FIBER OPTIC SENSOR (FOS) WAS NOT RECOGNIZED. NEVERTHELESS, THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE PATIENTS LEFT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) THERAPY WAS DIFFICULT TO PROVIDE DUE TO NO RECOGNITION OF THE FIBER OPTIC SENSOR (FOS) BY THE CONSOLE AND ANOTHER ERROR MESSAGE. (THE SALES REP WAS UNABLE TO FIND ANYONE WHO RECALLS THE ERROR MESSAGE). THE CARDIOLOGIST DECIDED TO REMOVE THE INTRA-AORTIC BALLOON (IAB) AND REPLACE IT WITH A NEW (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790086 FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FOS DSP ARROW INTERNATIONAL INC. 18R14M0026

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR