BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 206341 · Received January 13, 1999

    Report

    Report Number
    2248146-1998-01185
    Event Type
    Injury
    Date Received
    January 13, 1999
    Date of Event
    December 21, 1998
    Report Date
    December 24, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POOR AUGMENTATION WAS NOTED DURING IABP. THE PT HAD A MASSIVE PULMONARY HEMORRHAGE. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY. ON 12/30/1998, THE FOLLOWING INFORMATION WAS REPORTED TO DATASCOPE: THE PT WAS ON REPRO AND HEPARIN AND EXPERIENCED PULMONARY HEMORRAGE SHORTLY AFTER ARRIVAL TO CRITICAL CARE AFTER CARDIAC CATH, ANGIOPLASTY AND IABP INSERTION. BRONCHOSCOPY SHOWED NO LOCALIZED BLEEDING. GENERALIZED BLEEDING WAS NOTED FROM BOTH LUNGS. EVENT COMPLICATIONS: MASSIVE PULMONARY HEMORRHAGE - REPORTED 12/24/1998. PT'S CURRENT STATUS: UNK - REPORTED 12/24/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| O