BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 137831 · Received December 11, 1997

    Report

    Report Number
    2248146-1997-01366
    Event Type
    Death
    Date Received
    December 11, 1997
    Date of Event
    November 4, 1997
    Report Date
    December 4, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY. THE PHYSICAL EVIDENCE AND REPORTED PROBLEM ARE CONSISTANT WITH THAT OF AN IAB WHICH BECAME ENTRAPPED AND WAS SURGICALLY REMOVED FROM THE PATIENT. THE SMOOTH-EDGED PENETRATION(S) MOST LIKELY RESULTED WHEN THE BALLOOON MEMBRANE CAME IN CONTACT WITH A SHARP-EDGED INSTRUMENT DURING THE REMOVAL PROCESS. ALTHOUGH THE PATIENT CONSEQUENCES OF BALLOON PENETRATION REMAIN OVERWHELMINGLY BENIGN, GENERALLY NECESSITATING ONLY THE REMOVAL OF THE BALLOON AND ITS POSSIBLE REPLACEMENT, THE MEDICAL COMMUNITY IS BECOMING INCREASINGLY AWARE OF THE "ENTRAPPED BALLOON" PHENOMENON. SINCE IT IS POSSIBLE FOR A SMALL LEAK TO BE SELF LIMITING, THE BLOOD WITHIN THE BALLOON MAY DEHYDRATE UNDER THE CONTINUED ACTION OF HELIUM TO FORM A HARD CLOT DURING INTRA-AORTIC BALLOON PUMPING, BEFORE ENOUGH BLOOD ENTERS TO BECOME VISIBLE IN THE CATHETER. THIS CLOT MAY PREVENT PERCUTANEOUS REMOVAL OF THE BALLOON CAUSING IT TO BECOME "ENTRAPPED" IN THE ARTERY. BALLOON ENTRAPMENT NECESSITATING SURGICAL REMOVAL HAS BEEN REPORTED IN LITERATURE AND HAS BEEN EXPERIENCED BY USERS OF INTRA-AORTIC BALLOONS. WE THEREFORE URGE THE USER, AS WE HAVE DONE IN OUR INSTRUCTIONS, TO DISCONTINUE PUMPING AND CONSIDER THE REMOVAL OF THE BALLOON FROM THE PATIENT AT ONCE IF A BALLOON LEAK IS SUSPECTED. IF FOR ANY REASON, UNDUE RESISTENCE IS MET DURING REMOVAL OF THE BALLOON, THE USER WOULD BE WELL ADVISED TO CALL FOR A VASCULAR CONSULTATION, AS WAS DONE IN THIS CASE.

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 10/9/97. ON 11/7/97 AT 1:00 A.M. AN ALARM SOUNDED FROM THE PUMP AND BLOOD LEAKED INTO THE CATHETER. THE FACILITY CONTINUED PUMPING AND THE DR REMOVED THE IAB SURGICALLY ON 11/9/97. THE PT WENT ON TO EXPIRE. IT WAS REPORTED THAT AS A RESULT OF THE EVENT, THE PT EXPIRED (DATE UNK). (EVENT COMPLICATIONS: THE IAB WAS SURGICALLY REMOVED/EXPIRED-) REPORTED 12/4/97. (PT'S CURRENT STATUS: EXPIRED-RPT'D 12/4/97.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0784-00-0115 03/04/99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death