BEUDAMED
    FDA Adverse Event Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 128992 · Received October 28, 1997

    Report

    Report Number
    2248146-1997-01142
    Date Received
    October 28, 1997
    Report Date
    October 13, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE QUALITY ASSURANCE DEPARTMENT OF THE DATASCOPE CORPORATION'S CARDIAC ASSIST DIVISION BECAME AWARE OF AN INCIDENT ON 10/13/97 WHICH WAS REPORTED IN THE 10/3/97 ISSUE OF "HEALTH DEVICES ALERTS". THE ARTICLE WAS ORGINALLY PUBLISHED IN THE 6/1997 ISSUE OF "EUROPEAN JOURNAL OF CARDIOTHORACIC SURGERY"-VOLUME 11(6); PAGES 1176-1179. THE FOLLOWING INFO WAS REPORTED: THE PT WAS RECOVERING FROM MITRAL VALVE REPLACEMENT AND CORONARY BYPASS SURGERY. A CHEST X-RAY FOLLOWING THE PROCEDURE REVEALED THE CATHETER TIP TOUCHING THE UPPER CONTOUR OF THE AORTIC ARCH. EIGHTEEN HRS AFTER THE IAB CATHETER WAS REMOVED, THE PT DEVELOPED SERVE CHEST PAIN, AND A SUBSEQUENT X-RAY REVEALED INCREASED MEDIASTINAL WIDENING AND A LEFT PLEURAL EFFUSION. AN EMERGENCY THORACOTOMY WAS PERFORMED AFTER COMPUTED TOMOGRAPHY SCANNING REVEALED A LARGE MEDIASTINAL HEMATOMA AND HEMOTHORAX. A PERFORATION OF THE POSTERIOR AORTIC WALL AT THE LEFT SUBCLAVIAN ARTERY WAS REPAIRED AND THE PT. RECOVERED WITHOUT FURTHER INCIDENT. (EVENT COMPLICATIONS: CHEST PAIN/HEMATOMA/INJURY TO ARTERY-REPORTED 10/13/97. (PT'S CURRENT STATUS: RECOVERED-RPT'D-10/13/97.

    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 69 YR Life Threatening| R