BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 167152 · Received May 8, 1998

    Report

    Report Number
    2248146-1998-00513
    Event Type
    Malfunction
    Date Received
    May 8, 1998
    Date of Event
    April 28, 1998
    Report Date
    May 5, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: 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 IABP. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 7/8/98).

    Description of Event or Problem · 1

    THE IAB LEAKED AND WAS REMOVED. ANOTHER IAB WAS INSERTED INTO THE PT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER, 98-00542, 98-00544). ON 6/10/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE "CHECK INTRA-AORTIC BALLOON CATHETER" ALARM SOUNDED FROM THE PUMP BLOOD WAS FOUND IN THE LINE. THE CARDIOLOGIST WAS CALLED AND PUMPING WAS STOPPED. THE INTRA AORTIC BALLOON WAS REMOVED IN THE CATH LAB AND ANOTHER WAS INSERTED. THE PT WAS RETURNED TO CORONARY CARE UNIT. IT IS UNK IF THERE WERE ANY PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PT IS SLOWLY RECOVERING, REMAINS ON A VENTILATOR, AND IS VAGUELY RESPONSIVE. [EVENT COMPLICATIONS]: UNK-REPORTED 5/5/98 AND 6/10/98. [PT'S CURRENT STATUS]: RECOVERING-RPT'D 6/10/98.

    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. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR