BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 164911 · Received April 27, 1998

    Report

    Report Number
    2248146-1998-00427
    Event Type
    Injury
    Date Received
    April 27, 1998
    Date of Event
    April 10, 1998
    Report Date
    April 13, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 5/13/98).

    Description of Event or Problem · 1

    AFTER THE IAB WAS INSERTED INTO THE PT, THERE WAS INJURY TO THE PT'S ARTERY. THE IAB WAS REMOVED AND ANOTHER WAS NOT INSERTED. SURGERY WAS NEEDED TO REPAIR THE PT'S ARTERY. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00449). THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVAL. THE IAB WAS DISCARDED BY THE FACILITY. ON 5/6/98, THE FOLLOWING INFO WAS REPORTED TO DATASCOPE. THE IAB WAS INSERTED INTO THE PT ON 4/10/98 AT 1:15 PM. THE IAB DID NOT MALFUNCTION. A VASCULAR SURGEON WAS CONSULTED. THERE WAS BLEEDING AROUND THE IAB. THIS REQUIRED SURGICAL REPAIR OF LACERATION AND A TRANSFUSION. [EVENT COMPLICATIONS]: BLEEDING/INJURY TO ARTERY/SURGERY/TRANSFUSION-RPT'D 5/6/98. [PT'S CURRENT STATUS]: DISCHARGED-RPT'D 5/6/98.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention