BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 30 CC

    MDR report key: 2922174 · Received January 16, 2013

    Report

    Report Number
    1219856-2013-00014
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    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 THE EVENT INVOLVED A MALE PATIENT WHILE IN THE CARDIOLOGY DEPARTMENT DURING INSERTION. DURING PRODUCT PREP THE INTRA-AORTIC BALLOON (IAB) WAS VACUUMED COMPLETELY BEFORE THE IAB WAS REMOVED FROM THE TRAY. THE VASCULAR SURGEON ATTEMPTED TO INSERT THE IAB THROUGH THE ULTRA FLEX SHEATH VIA LEFT FEMORAL ARTERY AND IT COULD NOT ADVANCE. AS A RESULT, THE IAB, SHEATH AND SPRING WIRE GUIDE WERE ALL REMOVED TOGETHER. A NEW KIT WAS OPENED AND INSERTED VIA THE SAME INSERTION SITE SUCCESSFULLY. THERE WAS AN APPROXIMATE 10 MINUTE DELAY OR INTERRUPTION IN THERAPY NOTED WITH NO HARM TO THE PATIENT. THERE WAS NO REPORT OF PATIENT DEATH. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME WAS THE PATIENT WAS NOT INJURED AND HAD NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23494 IAB: 7.5 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF1122014

    Patients

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