BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1757183 · Received June 18, 2010

    Report

    Report Number
    1219856-2010-00408
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 15, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 INSERTION SITE WAS THE RIGHT FEMORAL ARTERY. ACCORDING TO RN, DURING THE FIRST INSERTION ATTEMPT, THE PROXIMAL END OF THE INTRA-AORTIC BALLOON (IAB) BECAME STUCK IN THE DISTAL END OF THE SUPER ARROW-FLEX (SAF) SHEATH AND WOULD NOT PASS IN EITHER DIRECTION. THE CATHETER AND SHEATH WERE REMOVED; THE SPRING WIRE GUIDE (SWG) WAS KEPT IN PLACE. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. THERE WAS NO REPORTED MEDICAL / SURGICAL INTERVENTION REQUIRED. THE DELAY IN THERAPY IS LISTED AS A "MODERATE DELAY." THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE RN STATED THAT THE DOCTOR DID NOT FEEL THAT THE PATIENT ANATOMY CONTRIBUTED TO THE DIFFICULTY. THE PATIENT OUTCOME IS "NO HARM TO PATIENT, PATIENT CURRENTLY ON PUMP." REFERENCE MDR #1219856-2010-00409 FOR THE SECOND EVENT INVOLVING THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC. MF0010931

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR INTRA-AORTIC BALLOON PUMP