BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 189866 · Received September 29, 1998

    Report

    Report Number
    2248146-1998-01098
    Event Type
    Injury
    Date Received
    September 29, 1998
    Date of Event
    September 20, 1998
    Report Date
    September 22, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01176) AFTER IABP FOR ABOUT 15 HOURS, THE BALLOON RUPTURED. THE DOCTOR WAS UNABLE TO REMOVE THE IAB. THE IAB WAS ENTRAPPED AND THE PATIENT HAD TO BE TAKEN TO THE O.R. FOR IAB REMOVAL. NO SECOND IAB WAS INSERTED INTO THE PATIENT. ON 10/13/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE PUMP ALARM SOUNDED. THE BALLOON RUPTURED REQUIRING RIGHT FEMORAL ARTERY EXPLORATION. THE IAB COULD NOT BE REMOVED BY PULLING IT BACK. THE IABE HAD TO BE SURGICALLY REMOVED. DURING SURGERY AN EMBOLECTOMY WAS PERFORMED ON THE DISTAL FEMORAL ARTERY. REPAIR TO THE ARTERY WAS ALSO DONE. AS OF 9/29/98, THE PATIENT REMAINED STABLE BUT STILL HOSPITALIZED. [EVENT COMPLICATIONS]: THE IAB WAS ENTRAPPED/SURGICALLY REMOVED - REPORTED 9/22/98. [PATIENT'S CURRENT STATUS]: STABLE - RPT'D 9/24/98.

    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. 0684-00-0321 07/12/00

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention