BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIDELITY IAB BALLOON CATHETER

    MDR report key: 585318 · Received March 16, 2005

    Report

    Report Number
    585318
    Event Type
    Other
    Date Received
    March 16, 2005
    Date of Event
    March 4, 2005
    Report Date
    March 16, 2005
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS CONNECTED TO A DATASCOPE INTRAAORTIC BALLOON PUMP, MODEL CS100, WHEN THE BALLOON CATHETER RUPTURED. THE PUMP DISPLAYED A MESSAGE SAYING " CHECK CATHETER ". THE OPERATOR NOTICED THERE WAS BLOOD IN THE CATHETER TUBING SO THE THE PUMP WAS TURNED OFF, THE FAULTY CATHETER REMOVED AND REPLACED. THE RUPTURED ITEM WAS SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS. TREATMENT WAS CONTINUED WITHOUT FURTHER PROBLEMS REGARDING THIS UNIT. THE MALFUNCTION WAS NOT HARMFUL TO THE PATIENT

    Description of Event or Problem · 1

    THE 34 CC FIDELITY 8FR. IAB WAS VISUALLY EXAMINED, LAB LEAK TESTS AND A PHOTOGRAPHIC IMAGE OF THE PRODUCT WERE TAKEN. THE EVAL REVEALED A SMOOTH-EDGED PENETRATION IN THE BALLOON MEMBRANE. IN ADDITION, A WITHISH ABRASION PATCH ACCOMPANIED THE PENETRATION. THE MICROSCOPIC APPEARANCE OF THE MEMBRANE PENETRATION AND THE SURROUNDING ABRADED AREA IS CONSISTENT WITH REPEATED CONTACT WITH CALCIFIED PLAQUE DURING COUNTERPULSATION THERAPY. IF YOU REQUIRE FURTHER INFO, PLEASE CONTACT ME AT 973-244-6104.

    Description of Event or Problem · 1

    THE IAB WAS VISUALLY EXAMINED; BLOOD WAS VISIBLE ON THE EXTERIOR AND WITHIN THE ENTIRE IAB. AN 8FR REINFORCED DATASCOPE SHEATH WAS RETURNED ON THE CATHETER AND WAS FOUND TO BE COVERING THE PROXIMAL TAPER OF THE MEMBRANE. THE LAB TECHNICIAN WAS ABLE TO REMOVE THE SHEATH FROM THE MEMBRANE AND PERFORM THE LABORATORY LEAK TESTS. A SMOOTH-EDGED PENETRATION WAS FOUND IN THE MEMBRANE AND PERFORM THE LABORATORY LEAK TESTS. A SMOOTH-EDGED PENETRATION WAS FOUND IN THE MEMBRANE THAT IS LOCATED 9.0" FROM THE IAB DISTAL TIP. ACCOMPANYING THE PENETRATION IS A WHITISH ABRASION PATCH THAT MEASURES.100" IN LENGTH. ALSO OBSERVED NEAR THE LEAK SITE WERE RIDGED PARALLEL LINES, THESE LINES ARE TYPICALLY PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR FOLDING. THE MICROSCOPIC APPEARANCE OF THE PENETRATION AND OF THE SURROUNDING ABRADED AREA IS TYPICAL OF THOSE CAUSED BY REPEATED CONTACT WITH CALCIFIED PLAQUE DURING INTRA-AORTIC BALLOON PUMPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIDELITY IAB BALLOON CATHETER BALLOON CATHETER DSP DATASCOPE CORPORATION FIDELITY CS100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *