BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL DH-37 IAB

    MDR report key: 145017 · Received January 15, 1998

    Report

    Report Number
    2248146-1998-00031
    Event Type
    Malfunction
    Date Received
    January 15, 1998
    Date of Event
    January 8, 1998
    Report Date
    January 9, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: 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.

    Description of Event or Problem · 1

    EVENT: (CC# 98-00032) ON 1/6/1998, THE IAB WAS INSERTED INTO PT TRANSTHORACICALLY. ON 1/8/1998, THE IAB LEAKED AND THE IAB WAS REMOVED. ON 1/14/1998, THE FOLLOWING INFO WAS REPORTED TO DATACOPE: THE IAB WAS INSERTED INTO THE PT ON 1/6/1998 AT 12:20 P.M. ON 1/8/1998 AT 12:00 A.M. AFTER IABP FOR ABOUT 35 HRS, THE IAB LEAKED AND THE IAB WAS REMOVED. NO SECOND IAB WAS INSERTED. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 2/3/1998: THE NURSE NOTED BLOOD IN THE CONNECTING TUBING AND THE PUMP WAS PUT ON STAND-BY MODE. SHE THEN ASPIRATED THE BALLOON WITH A SYRINGE AND BLOOD WAS NOTED IN THE SYRINGE. THE CONSOLE WAS SHUT OFF AND THE CATHETER WAS CLAMPED OFF WITH FORCEPS. THE PT RETURNED TO THE O.R. AND THE IAB WAS REMOVED. THERE WAS NO PT INJURY OD COMPLICATION AS A RESULT OF THE EVENT. THE PT REMAINED HEMODYNAMICALLY STABLE IN ICU. ON 2/23/1998, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FROM FROM THE FACILITY; UF/DIST REPORT NUMBER: 4501930000-1998-004 AND THE FOLLOWING INFO WAS REPORTED: THE IAB WAS INSERTED INTO THE PT ON 1/6/1998. THE TRANSTHORACIC APPROACH WAS DONE DUE TO HIGHLY CALCIFIED AORTA. THE IAB WAS REMOVED IN THE O.R. ON 1/8/1998. NO DELETERIOUS AFFECTS WERE NOTED. THE PT REMAINED STABLE IN THE ICU. [EVENT COMPLICATIONS]: UNK - REPORTED 1/9/1998; NONE - REPORTED 1/14/1998 AND 2/3/1998. [PT'S CURRENT STATUS]: STABLE IN ICU-RPT'D 2/3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL DH-37 IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0009-04 10/20/98

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR