BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2150540 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00208
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR CONTROL NO (B)(4). ADD'L INFO RECEIVED ON (B)(4) 2011 STATED THAT ON (B)(4) 2011 EDUCATION PROVIDED TO FELLOWS REGARDING PROPER IAB PREP AND INSERTION TECHNIQUE, IABP BASIC SET UP AND BASIC TROUBLESHOOTING. ALSO, EDUCATED AS TO PROPER STEPS TO REMOVE AN IAB AND INFORMED TO NEVER REMOVE IAB OUT OF THE SHEATH PER OUR PRODUCT IFUS. FELLOWS WERE REFERRED TO IAB IFUS AS WELL AS ONLINE EDUCATION AND INSERTION VIDEO. FELLOWS VERBALIZED UNDERSTANDING STEPS BACK AS A GROUP FOR PROPER IAB PREP AND STEPS OF INSERTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON A REGULAR VISIT TO THE MED CTR, THE SALES REP (SR) ASKED THE MD IF HE HAD ANY QUESTIONS REGARDING INTRA-AORTIC BALLOON PUMPS (IABP'S). THE MD QUESTIONED ABOUT THE PREP OF AN INTRA-AORTIC BALLOON (IAB) SINCE THIS EVENT OCCURRED A "COUPLE WEEKS AGO." THE INSERTION SITE WAS THE FEMORAL ARTERY. INDICATION FOR USE: SUPPORT DURING HIGH RISK ANGIOGRAPHY CASE. PER THE MED "THE IAB WAS INFLATED PRIOR TO PLACEMENT INTO THE SHEATH (INCORRECT PREP), PULLED NEGATIVE AND WAS ABLE TO INSERT THE IAB INTO THE SHEATH. NO BLOOD WAS NOTED BACK FROM THE CENTRAL LUMEN AND THE IAB WAS ATTEMPTED TO BE PULLED OUT THROUGH THE SHEATH WITHOUT SUCCESS." THE MD ALSO STATED THAT "THE IAB WAS IN PROPER PLACEMENT (JUST BELOW ARCH), HOWEVER HE DOES NOT REMEMBER DETAILS ABOUT THE SPRING WIRE GUIDE (SWG), IF CENTRAL LUMEN WAS FLUSHED PRIOR TO INSERTION, ETC." EXACT IAB INFO WAS NOT AVAILABLE AS THE IAB AND PACKAGING WERE THROWN OUT. THE IAB AND SHEATH WERE REMOVED TOGETHER WITHOUT INCIDENT. THE PT WENT FOR CABG (CORONARY ARTERY BYPASS GRAFT) SURGERY AT A LATER TIME. AS A RESULT, THE MD RECONSIDERED THE NEED FOR THERAPY AND THERE WAS NOT ANOTHER ATTEMPT AT THE PROCEDURE MADE. THERE WAS NO MEDICAL/SURGICAL INTERVENTION NEEDED. THERE WAS NO DELAY IN THERAPY. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT OUTCOME IS OKAY. THE SR REVIEWED PROPER IAB PREP, INSERTION AND REMOVAL WITH THE MD. ALSO, THE MD WAS GIVEN A TELEFLEX IAB INSERTION DVD FOR HIS REVIEW. THE MD THANKED THE SR FOR THE INFO AND REVIEWING THE PREP PROCEDURE WITH HIM. THE MD STATED THAT HE PLANNED ON WATCHING THE DVD AND WOULD SHARE THE INFO WITH THE FELLOWS. ADD'L INFO RECEIVED ON (B)(4) 2011 FROM THE SR STATED THEY HAD INFLATED THE IAB PRIOR TO INSERTING INTO THE SHEATH, THEY PULLED NEGATIVE AGAIN AND HAD COLLAPSED THE IAB ENOUGH TO INSERT INTO THE SHEATH. THEN WHEN THEY DID NOT GET BLOOD BACK IN THE LUMEN AFTER THE SWG WAS REMOVED, THEY ATTEMPTED TO PULL THE IAB OUT THROUGH THE SHEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK