BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR 40 CC IAB

    MDR report key: 160495 · Received March 30, 1998

    Report

    Report Number
    2248146-1998-00350
    Event Type
    Malfunction
    Date Received
    March 30, 1998
    Date of Event
    February 14, 1998
    Report Date
    March 19, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    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. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 5/21/98).

    Description of Event or Problem · 1

    THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING AND IABP WAS DISCONTINUED. (DATASCOPE REC'D THIS REPORT ON 3/19/98 VIA THE VOLUNTARY MEDWATCH FORM FROM THE FDA; MDR ACCESS NUMBER: 1013101). ON 5/4/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLACK FLAKES WERE FOUND IN THE GAS LINE. THERE WAS NO PT INJURY OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PT WAS DISCHARGED FROM THE FACILITY ON 3/2/98. [EVENT COMPLICATIONS]: UNK-REPORTED 3/19/98; NONE-RPT'D 5/4/98. [PT'S CURRENT STATUS]: DISCHARGED-RPT'D 5/4/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0321 01/09/00

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR