BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCOR STAT-DL DUAL LUMEN INTRA-AORTIC BALLOON CATHETER

    MDR report key: 595 · Received May 22, 1992

    Report

    Report Number
    595
    Event Type
    Injury
    Date Received
    May 22, 1992
    Date of Event
    April 11, 1992
    Report Date
    April 22, 1992
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S INTRA-AORTIC BALLOON CATHETER RUPTERED DURING TREATMENT IN THE ICU. THE PATIENT REQUIRED OPERATIVE INTERVENTION TO REMOVE IT. THE CATHETER IS TO BE SENT TO MANUFACTURER FOR ANALYSISDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN, BALLOON. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT-DL DUAL LUMEN INTRA-AORTIC BALLOON CATHETER Implant INTRA-AORTIC BALLOON CATHETER FOR OPTIONAL SHEATLESS INSERT. DSP DATASCOPE CORPORATION 0684-00-0255-01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention