BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188237 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01036
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    August 26, 1998
    Report Date
    September 2, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01111) THE DOCTOR WAS UNABLE TO INSERT THE IAB INTO THE SHEATH. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE SAME SHEATH. ON 10/2/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: SEVERAL ATTEMPTS WERE MADE TO PUSH THE IAB THROUGH THE SHEATH BUT IT WAS NOT POSSIBLE TO ADVANCE THE IAB. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PATIENT DID EVENTUALLY GO TO SURGERY. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/2/98; NONE - RPT'D 10/2/98. [PATIENT'S CURRENT STATUS]: TO SURGERY-RPT'D 10/2/98.

    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. 0684-00-0283 06/05/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN