BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 137795 · Received December 8, 1997

    Report

    Report Number
    2248146-1997-01334
    Event Type
    Malfunction
    Date Received
    December 8, 1997
    Date of Event
    November 19, 1997
    Report Date
    November 25, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIFFICULTY INSERTING IAB THROUGH SHEATH MAY BE ATTRIBUTED TO ONE OR MORE OF FOLLOWING: * USER MAY HAVE NOT DRAWN SUFFICIENT VACUUM ON BALLOON DURING ITS REMOVAL FROM BLISTER TRAY. * IF DRAWN, VACCUUM MAY HAVE NOT BEEN MAINTAINED THROUGHOUT INSERTION PROCEDURE. * DURING INSERTION AND ADVANCEMENT OF SHEATH, SHEATH MAY HAVE HIT OPPOSING WALL OF ARTERY CAUSING IT TO KINK. * PT MAY HAVE HAD SEVERE VESSEL TORTUOSITY RESULTING IN POOR BALLOON INSERTION AND ADVANCEMENT INTO SHEATH. * DURING INSERTION, BALLOON TIP MAY HAVE HIT OPPOSING WALL OF ARTERY AS IT EXITED END OF SHEATH. * CATHETER AND/OR LUMEN KINKED DURING INSERTION IF BALLOON WAS NOT SUPPORTED BY GUIDE WIRE. * CATHETER WAS HELD TOO FAR BACK FROM SITE OF INSERTION.

    Description of Event or Problem · 1

    EVENT: (CC# 97-01430) THE BALLOON CATHETER WAS REMOVED FROM THE PACKAGE AND EVACUATED PROPERLY. DURING INSERTION, IT WAS NOTED THAT THE BALLOON WAS NOT WRAPPED TIGHTLY ENOUGH TO PASS THROUGH THE SHEATH. THE IAB WAS REMOVED AND A SECOND WAS INSERTED. THE PT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION ON IAB SUPPORT. ON 1/29/1998, DATASCOPE WAS NOTIFIED THAT THE IAB WAS PROBABLY DISCARDED BY THE FACILITY AND WOULD NOT BE RETURNED FOR EVALUATION. THE DEVICE WAS FINALLY RETURNED TO DATASCOPE ON 2/11/1998. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 11/25/1997 AND 2/11/1998. [PT'S CURRENT STATUS]: STABLE - RPT'D 11/25/1997.

    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 06/13/99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN