BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 191065 · Received October 10, 1998

    Report

    Report Number
    2248146-1998-01146
    Event Type
    Injury
    Date Received
    October 10, 1998
    Date of Event
    September 28, 1998
    Report Date
    September 29, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01226) THE DOCTOR WAS UNABLE TO INSERT THE IAB INTO THE SHEATH . THE IAB WAS REMOVED AND ANOTHER WAS INSERTED AND WORKED FINE. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01225) ON 10/26/98 IT WAS REPORTED THAT THE IAB WAS ATTEMPTED TO BE PLACED INTO THE PATIENT BUT HE COULD NOT PASS THE CATHETER; LATER THE PATIENT BECAME MORE UNSTABLE AND A THIRD IAB WAS PLACED SUCCESSFULLY. [EVENT COMPLICATIONS]: THE PATIENT LOST PULSES - REPORTED 9/29/98. [PATIENT'S CURRENT STATUS]: DISCHARGED-RPT'D 10/26/98.

    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. 0684-00-0269 05/28/00

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention