BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1959199 · Received December 17, 2010

    Report

    Report Number
    1219856-2010-00904
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE INTENSIVE CARE UNIT THE MD INSERTED THE SPRING WIRE GUIDE (SWG) INTO THE PT'S RIGHT FEMORAL ARTERY USING THE SELDINGER TECHNIQUE. THE DILATOR WAS INSERTED AND THEN THE SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED INTO THE PT'S RIGHT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO THE SAF SHEATH AND ABOUT 1/2 OF THE DEVICE WAS INTRODUCED WHEN THE IAB BECAME STUCK IN THE SAF SHEATH. THE MD COULD NOT REMOVE THE IAB OR ADVANCE THE IAB THROUGH THE SAF SHEATH. AS A RESULT, THE MD URGENTLY REMOVED THE IAB AND SAF SHEATH AS ONE UNIT. THE PT REC'D A LARGE HEMATOMA IN THE RIGHT FEMORAL INSERTION SITE. ANOTHER IAB WAS INSERTED. THERE WAS NO REPORTED PT DEATH. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WAS DELAYED UNTIL THE IAB AND SAF SHEATH WERE REMOVED AND REPLACED. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INTRA-AORTIC BALLOON PUMP