BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188234 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01037
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    August 24, 1998
    Report Date
    September 3, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01112) BLOOD WAS NOTED IN THE BALLOON. THE DOCTOR HAD DIFFICULTY REMOVING THE IAB FROM THE PATIENT. A SECOND IAB WAS INSERTED INTO THE PATIENT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01113) THE FOLLOWING WAS REPORTED TO DATASCOPE ON 9/24/98: BLOOD WAS NOTED IN THE BALLOON LUMEN. THE RESIDENT WAS NOTIFIED TO OBSERVE. THE PHYSICIAN WAS MADE AWARE OF THIS. THERAPY WAS DISCONTINUED WITH SOME DIFFICULTY. ANOTHER IAB WAS INSERTED INTO THE RIGHT GROIN SEVERAL HOURS LATER IN THE CATH LAB. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. (ON 9/24/98, DATASCOPE RECEIVED THE MEDWATCH FORM FROM THE USER FACILITY; UF/DISTRIBUTOR REPORT NUMBER: 14-0258-1998-0156) [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/3/98 AND 9/24/98. [PATIENT'S CURRENT STATUS]: TRANSFERRED-RPT'D 9/3/98.

    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 64 YR