BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 2992958 · Received March 1, 2013

    Report

    Report Number
    1219856-2013-00044
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 7, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER CONTROL NO (B)(4). DEVICE EVALUATION: THE IAB WAS NOT RETURNED. A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDING. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF "THE FIBER OPTIC WIRE HAS BROKEN AND PUNCTURED THE BALLOON MEMBRANE" COULD NOT BE CONFIRMED. THE IAB WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIBEROPTIX SENSOR (FOS) WIRE HAD BROKEN AND PUNCTURED THE BALLOON MEMBRANE. ADDITIONAL INFORMATION RECEIVED ON 15FEB2013 STATED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH A SHEATH INTO THE PATIENT'S RIGHT FEMORAL ARTERY. THE PATIENTS' VESSELS WERE NOT TOO TORTUOUS. WHEN THE INTRA- AORTIC BALLOON PUMP (IABP) THERAPY STARTED THE PUMP ALARMED FOR A LEAKAGE. THE IAB WAS REMOVED WITH THE SHEATH AND SPRING WIRE GUIDE '4 (SWG) AS ONE UNIT USING THE SAME INSERTION SITE THE MD INSERTED ANOTHER IAB. THERE WAS A 30 MINUTE DELAY IN IABP THERAPY UNTIL THE NEW IAB WAS INSERTED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS NOR INJURY TO THE PATIENT. NO MEDICAL / SURGICAL INTERVENTION REQUIRED. THE PATIENT SURVIVED REFERENCE MDR #1219856-2013-00052 FOR THE RELATED IABP REPORT.

    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 FIBEROPTIX SENSOR (FOS) WIRE HAD BROKEN AND PUNCTURED THE BALLOON MEMBRANE. ADDITIONAL INFORMATION RECEIVED ON 02/15/2013 STATED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH A SHEATH INTO THE PATIENT'S RIGHT FEMORAL ARTERY. THE PATIENT'S VESSELS WERE NOT TOO TORTUOUS. WHEN THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY STARTED THE PUMP ALARMED FOR A LEAKAGE. THE IAB WAS REMOVED WITH THE SHEATH AND SPRING WIRE GUIDE (SWG) AS ONE UNIT. USING THE SAME INSERTION SITE THE MD INSERTED ANOTHER IAB. THERE WAS A 30 MINUTE DELAY IN IABP THERAPY UNTIL THE NEW IAB WAS INSERTED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS NOR INJURY TO THE PATIENT. NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT SURVIVED. REFERENCE MDR #1219856-2013-00052 FOR THE RELATED IABP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126189 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF1070709

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male INTRA-AORTIC BALLOON PUMP