BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 63633 · Received January 17, 1997

    Report

    Report Number
    2248146-1997-00005
    Event Type
    Death
    Date Received
    January 17, 1997
    Date of Event
    December 20, 1996
    Report Date
    January 3, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED INFO INDICATED BY "UNK" WAS EITHER NOT SUPPLIED OR NOT KNOWN BY THE CONTACT EVEN AFTER MULTIPLE ATTEMPTS. THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON: 07/08/1997. EVALUATION SUMMARY: 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 IABP.

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 12/20/96. AFTER IAB FOR 8 HRS, THE IAB LEAKED. THE PUMP ALARMED AND BLOOD WAS NOTED IN THE TUBING (THE PT WAS VERY BALLOON DEPENDENT). THE PT IMMEDIATELY BECAME HYPOTENSIVE AND MINS LATER, ARRESTED. THE PT WAS RESUSCITATED. A 2ND IAB WAS INSERTED INTO THE PT. AS A RESULT OF THE EVENT, THE PT'S BLOOD PRESSURE DROPPED AND THE PT WENT ON TO EXPIRE, DESPITE AGGRESSIVE MEDICAL THERAPY, WITH THE SECOND IAB IN PLACE APPROX 3 HRS LATER. THIS IAB DID NOT MALFUNCTION. THE CONTACT STATED THAT THE EVENT CONTRIBUTED TO THE PT'S DEATH. EVENT COMPLICATIONS: HYPOTENSION/EXPIRED-REPORTED 1/3/97. PT'S CURRENT STATUS: EXPIRED-RPT'D 1/3 & 1/7/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0283 11/15/98

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death