BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 161208 · Received April 1, 1998

    Report

    Report Number
    2248146-1998-00371
    Event Type
    Malfunction
    Date Received
    April 1, 1998
    Date of Event
    March 1, 1998
    Report Date
    March 23, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WS MAILED TO THE FDA ON 06/08/1998). EVALUATION: LABORATORY EXAMINATION OF THE RETURNED ITEM REVEALED NO DEFECT. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. TESTING FOR OCCULT BLOOD WITHIN THE BALLOON WAS NEGATIVE. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE EVENT DESCRIPTION AND PHYSICAL EVIDENCE, THERE WAS NO LEAK IN THE IAB. IT IS PROBABLE THAT DURING INSERTION, BLOOD FLOWED BETWEEN THE FOLDS OF THE MEMBRANE AND EXITED NEAR THE CATHETER-MEMBRANE JUNCTION, LEADING TO THE PERCEPTION THAT THE BALLOON HAD LEAKED. DATASCOPE HAS INCORPORATED THIS CHANNELING PHENOMENON IN ITS INSTRUCTIONS FOR USE FOR ALL STAT IABS.

    Description of Event or Problem · 1

    ON 05/19/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: ON INSERTION OF THE BALLOON THROUGH THE GROIN, BLOOD WAS NOTED TO GUSH OUT AT THE JOINT OF THE BALLOON AND THE CATHETER. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 03/01/1998. THE PT REMAINED IN GOOD CONDITION AFTER THE EVENT. (EVENT COMPLICATIONS): NONE FROM THE EVENT - REPORTED 03/23/1998 & 05/19/1998. (PT'S CURRENT STATUS): GOOD - REPORTED 05/19/1998.

    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 09/13/99

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR