BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 2193448 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00248
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 12, 2011
    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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EVENT OCCURRED IN THE CATH LAB DURING INSERTION. THE MD FOLLOWED THE INSTRUCTIONS FOR USE, HOWEVER, HE WAS UNABLE TO INSERT THE INTRA-AORTIC BALLOON (IAB) SMOOTHLY. HE FELT SEVERE RESISTANCE TOWARD THE CATHETER. HE DECIDED TO REMOVE THE CATHETER AND OPEN ANOTHER KIT. HE CONTINUED THE PROCEDURE AND THE IAB WAS PLACED SUCCESSFULLY. THERE WERE NO HARMFUL OUTCOMES FOR THE PT. THE LEFT FEMORAL ARTERY WAS THE INSERTION SITE FOR BOTH INSERTIONS. ADD'L INFO RECEIVED ON (B)(4) 2011 FROM THE DISTRIBUTOR STATED THE MD LEFT THE SPRING WIRE GUIDE (SWG) IN PLACE AND REMOVED THE SHEATH AND CATHETER TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF0053016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK