BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 126943 · Received October 16, 1997

    Report

    Report Number
    2248146-1997-01111
    Event Type
    Injury
    Date Received
    October 16, 1997
    Date of Event
    October 4, 1997
    Report Date
    October 10, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 ENTRAPPED AND NEEDED TO BE SURGICALLY REMOVED. THE BALLOON HAD A DARK "CRYSTAL LIKE" SUBSTANCE IN IT WHEN IT WAS REMOVED. IT LOOKED LIKE FREEZE DRIED COFFEE CRYSTALS. ON 10/24/97, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT #160064-1997-4. THE FOLLOWING INFO WAS REPORTED: THE IAB WAS INSERTED INTO THE PT ON 10/2/97. ON 10/4/97, THE DR WAS UNABLE TO REMOVE THE IAB. THE IAB WAS SURGICALLY REMOVED. ON 11/5/97 IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE IAB THROUGH THE ARTERIAL PUNCTURE SITE. EVENT COMPLICATIONS: THE IAB WAS ENTRAPPED/SURGICALLY REMOVED - REPORTED 10/10/97. PT CURRENT STATUS: UNK - RPT'D 10/10; 11/5/97.

    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. 0684-00-0306 09/26/99

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention