BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA IABP BALLOON CATHETER KIT

    MDR report key: 1462116 · Received July 1, 2009

    Report

    Report Number
    2032677-2009-00001
    Event Type
    Malfunction
    Date Received
    July 1, 2009
    Date of Event
    June 5, 2009
    Report Date
    June 5, 2009
    Manufacturer
    INSIGHTRA MEDICAL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K082746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED AND EVALUATED ON (B)(6), 2009. THE BALLOON WAS LODGED INSIDE THE INTRODUCER SHEATH WITH APPROXIMATELY 3CM PULLED THROUGH THE PROXIMAL END OF THE SHEATH AND APPROXIMATELY 10CM EXTENDING OUT THE DISTAL END OF THE SHEATH. THERE WAS NO EVIDENCE OF AIR TRAPPED INSIDE THE BALLOON. THERE WAS A KINK AT THE 65CM LOCATION AND A PERMANENT BEND IN THE INNER CATHETER 5CM FROM THE PROXIMAL END OF THE BALLOON. THE BALLOON WAS CAREFULLY REMOVED FROM THE DISTAL END OF THE INTRODUCER SHEATH. AFTER REMOVAL, THE BALLOON WAS INFLATED WITH 40CC AND APPEARED TO INFLATE NORMALLY WITH NO RESISTANCE TO INFLATION AND NO BLOOD INSIDE THE BALLOON. THE BALLOON WAS THEN OVERINFLATED AND NO LEAKS WERE IDENTIFIED. THE BALLOON COMPLETELY DEFLATED WHEN A NEGATIVE PRESSURE WAS DRAWN. THE EVAL WAS UNABLE TO VERIFY THE PROBLEM REPORTED BY THE USER. IT SHOULD BE NOTED THAT THE PHYSICIAN ACKNOWLEDGED THAT THEY DID NOT PRELOAD THE BALLOON PRIOR TO PUMPING AS REQUIRED AND STATED IN THE IFU. ADDITIONALLY, THE IFU STATES THAT THE IAB CATHETER SHOULD NOT BE REMOVED THROUGH THE SHEATH.

    Description of Event or Problem · 1

    THE IAB CATHETER WAS INSERTED IN A PT THAT WAS IN CARDIOGENIC SHOCK, USING SUPPLIED SHEATH AND STANDARD SELDINGER TECHNIQUE. AFTER BEING PLACED INTO POSITION, THE CATHETER WAS CONNECTED TO A DATASCOPE PUMP AND PUMPING WAS INITIATED, BUT WAS DISCONTINUED WHEN THE PUMP ALARMED, INDICATING EITHER A RESISTANCE TO FLOW AND/OR AN INABILITY OF THE BALLOON TO COMPLETELY INFLATE. THE BALLOON WAS EXAMINED FLUOROSCOPICALLY AFTER INFUSING A SMALL AMOUNT OF CONTRAST MEDIA THROUGH THE DISTAL LUMEN, WHICH INDICATED THAT THE BALLOON WAS ONLY PARTIALLY INFLATED AT THE PROXIMAL END. PUMPING WAS REINITIATED, BUT ALARMED AGAIN AND THE PHYSICIAN DECIDED TO REMOVE THE CATHETER AND REPLACE IT WITH ANOTHER. A VACUUM WAS THEN DRAWN ON THE BALLOON AND THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER THROUGH THE SHEATH, BUT THE BALLOON BECAME STUCK IN THE MIDDLE OF THE SHEATH. IT WAS BELIEVED THAT GAS WAS TRAPPED INSIDE THE BALLOON AND THE PHYSICIAN USED A SECONDARY PUNCTURE, DISTAL TO THE INSERTION SITE, TO ADVANCE A NEEDLE AND REMOVE GAS FROM THE BALLOON. THE CATHETER AND SHEATH WERE THEN REMOVED FROM THE PT AS A UNIT AND REPLACED WITH ANOTHER. THERE WAS A DELAY IN ADMINISTERING IABP TREATMENT. AFTER RECEIVING IABP TREATMENT FOR THREE DAYS, THE PT RECOVERED IN THE ICU. THERE WAS AN EXTENDED COURSE OF RECOVERY BUT THE PT'S OUTCOME WAS FINE. THE PT SUBSEQUENTLY UNDERWENT A PTCA PROCEDURE, HAD A STENT PLACED, AND WAS THEN RETURNED TO THE REFERRING HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA IABP BALLOON CATHETER KIT SYST, BALLOON, INTRA-AORTIC AND CONTROL DSP INSIGHTRA MEDICAL, INC. IMU7F-40 8091608

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention DATASCOPE IAB PUMP