BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 3063322 · Received April 11, 2013

    Report

    Report Number
    1219856-2013-00092
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 9, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    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 WHILE IN THE CATH LAB, THE SPRING WIRE GUIDE (SWG) AND SHEATH WERE INSERTED WITHOUT DIFFICULTY INTO THE PATIENT'S LEFT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED OVER THE SWG WITHOUT DIFFICULTY. HOWEVER, WHEN THE IAB WAS POSITIONED IN PLACE, THE MD AND TECH HAD DIFFICULTY REMOVING THE SWG FROM THE IAB REQUIRING EXTRA FORCE TO PULL THE SWG OUT OF THE IAB. AS A RESULT, THEY REMOVED THE IAB AND SWG THROUGH THE SHEATH. THEN, A SECOND KIT WAS OPENED FOR USE. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A REPORTED MINIMAL DELAY/INTERRUPTION IN INTRA-AORTIC BALLOON PUMP (IABP) THERAPY. THE PATIENT OUTCOME IS GOOD, NO COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 STATED THAT AFTER REMOVING THE IAB AND SWG FROM THE PATIENT, THE SWG WAS NOT UNRAVELED NOR WAS THE SWG FRAYED. THE SWG WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156913 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KS3015121

    Patients

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