BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC

    MDR report key: 2033927 · Received February 11, 2011

    Report

    Report Number
    1219856-2011-00051
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 24, 2010
    Report Date
    February 10, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    Z-0790/0793-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 CARDIAC CARE UNIT, THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PATIENT'S LEFT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS PASSED THROUGH THE SAF SHEATH AND BECAME STUCK INSIDE THE SHEATH. THE MD REMOVED THE IAB AND SAF SHEATH AS ONE UNIT. THE MD INSERTED THE SAME SAF SHEATH INTO THE PT AND THE SAME IAB THROUGH THE SHEATH. AGAIN, THE IAB BECAME STUCK IN THE SAF SHEATH. AT THIS TIME, THE IAB AND SAF SHEATH WERE REMOVED AND A DATASCOPE IAB WAS PREPPED AND USED WITHOUT DIFFICULTY. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE THERAPY WAS DELAYED FOR 20 MINUTES. THERE WERE NO REPORTED PT COMPLICATIONS. THE OUTCOME OF THE PT IS "THE PT SUCCESSFULLY REC'D HIS IABP THERAPY" ADD'L INFO REC'D ON (B)(6) 2011 FROM THE DISTRIBUTOR STATED THAT "MD THOUGHT THAT HE MIGHT PERFORM INSERTION PROCEDURE INCORRECTLY FOR THE FIRST ATTEMPT. THEN HE HAS TRIED THE SECOND ATTEMPT, BUT IT WAS UNSUCCESSFUL. YES, HE DID THE SAME SITE BY USING THE SPRING WIRE GUIDE TO INSERT THE NEW BALLOON CATHETER."

    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. MF0053019

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR DATASCOPE INTRA-AORTIC BALLOON