BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 169708 · Received May 22, 1998

    Report

    Report Number
    2248146-1998-00580
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Date of Event
    May 19, 1998
    Report Date
    May 19, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 7/8/1998) EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING INTRA AORTIC BALLOON PUMP.

    Description of Event or Problem · 1

    FOLLOWING WAS REPORTED TO DATASCOPE ON 6/10/1998: THERE WAS NO PT INJURY OR COMPLICATION AS RESULT OF EVENT. ANOTHER INTRA-AORTIC BALLOON WAS NOT INSERTED. PT WAS STABLE AFTER EVENT AND WAS IN GOOD CONDITION. [EVENT COMPLICATIONS]: NONE FROM EVENT - REPORTED AND 6/10/1998. [PT'S CURRENT STATUS]: STABLE - RPT'D 6/10/1998.

    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. 0684-00-0269 02/22/99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN