BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 132667 · Received November 13, 1997

    Report

    Report Number
    2248146-1997-01224
    Event Type
    Malfunction
    Date Received
    November 13, 1997
    Report Date
    November 7, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1: 1738 DEVICE LABEL CODE FOR POSITION 2: 1738 DEVICE LABEL CODE FOR F10. POSITION 3: 1701

    Description of Event or Problem · 1

    EVENT: (CC# 97-01345) THE IAB LEAKED. THIS WAS THE ONLY INFO AT THE TIME OF THE REPORT. ON 12/18/1997, THE FOLLOWING WAS REPORTED TO DATASCOPE: DURING IAB INSERTION, THE PHYSICIAN THOUGHT THE BALLOON HAD A HOLE IN IT. WHILE INSERTING THE BALLOON, BLOOD WAS NOTED COMING UP THROUGH THE BALLOON. THE CARDIAC CATH LAB MANAGER TOLD THE PHYSICIAN THAT THE BLOOD WAS COMING THROUGH THE WRAPPING OF THE BALLOON BUT THE PHYSICIAN DID NOT AGREE WITH HIM. THE PHYSICIAN REQUESTED TO USE ANOTHER IAB. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 11/7/1997 AND 12/18/1997. [PT'S CURRENT STATUS]: UNKNOWN - RPT'D 12/18/1997.

    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. 0684-00-0283 2/28/1999

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR