BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 169333 · Received May 22, 1998

    Report

    Report Number
    2248146-1998-00558
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Date of Event
    September 29, 1997
    Report Date
    May 15, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE IAB WAS RETURNED WITH THE MEMBRANE NOTED TO BE COMPLETELY FOLDED. 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 INCORPORATES THIS CHANNELING PHENONEMON INTO ITS INSTRUCTIONS FOR USE FOR ALL STAT IABS.

    Description of Event or Problem · 1

    EVENT: (CC# 98-00591) IAB LEAKED DURING INSERTION. ON 6/10/1998 FOLLOWING WAS REPORTED TO DATASCOPE: DR PERFORMED CABG SURGERY ON 70 YR OLD PT WITH 100% LEFT MAIN LESION. HE HAD HEMODYNAMIC COMPROMISE AFTER BEING WEANED OFF CARDIOPULMONARY BYPASS AND IT WAS DECIDED TO SUPPORT HIM ON IABP. DR INTRODUCED SHEATH BY SELDINGER TECHNIQUE INTO RIGHT FEMORAL ARTERY. WHEN BALLOON WAS INTRODUCED INTO SHEATH OVER GUIDE WIRE FOR JUST 2-4 INCHES HE COULD SEE BLOOD INSIDE BALLOON. BLOOD WAS REGURGITATING INTO BALLOON. IAB WAS REMOVED AND ANOTHER INSERTED. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF EVENT. (MULTIPLE COMPLAINT TO CC# 98-00589, 98-00590, 98-00592) [EVENT COMPLICATIONS]: UNK - REPORTED 5/15/1998; NONE - REPORTED 6/10/1998. [PT'S CURRENT STATUS]: UNK - 5/15/1998, 6/10/1998

    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. 0684-00-0283 07/04/99

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR