BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8FR - 30 CC

    MDR report key: 1482060 · Received July 23, 2009

    Report

    Report Number
    1219856-2009-00350
    Event Type
    Malfunction
    Date Received
    July 23, 2009
    Date of Event
    July 13, 2009
    Report Date
    July 23, 2009
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR # 1219856-2009-00349 FOR FIRST EVENT INVOLVING SAME PATIENT (PT). IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE SECOND SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED & IAB AGAIN BECAME STUCK IN SAF SHEATH. AS A RESULT, MD ELECTED TO USE THE NON-SAF SHEATH (TEFLON SHEATH) & ACCESS WAS OBTAINED. PT TOLERATED PROCEDURE WELL & REMAINS IN STABLE CONDITION. ADDITIONAL INFO RECEIVED ON 7/20/09 FROM SALES REP STATES: JULY 17, 2009, UPON MEETING WITH PERFUSION SERVICES, DETAILS ARE AS DESCRIBED: PT IN CATH LAB, MD OPENED ANOTHER IAB-05830-U. DUE TO DIFFICULTY WITH PRIOR INSERTION INTO SAF SHEATH, MD ATTEMPTED TO INSERT IAB, WHILE WRAPPED, INTO SAF SHEATH WHILE ALL ON STERILE TABLE. STILL ENCOUNTERED DIFFICULTY INSERTING INTO SAF, ELECTED TO USE TEFLON SHEATH & BOTH TEFLON SHEATH & IAB INSERTED WITHOUT INCIDENT. MD IS QUITE FAMILIAR WITH ARROW IAB TRAYS & INSERTION PROCESS. PERFUSION DID ASK MD IF SHE WOULD LIKE TO TURN IAB CLOCKWISE TO AID IN INSERTION OF IAB INTO SAF SHEATH, WHICH WAS DECLINED. AS OF (B)(6), 2009, IAB REMAINS IN PT & PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF9056839

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK