BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 169744 · Received May 22, 1998

    Report

    Report Number
    2248146-1998-00557
    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

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 07/08/1998). EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE IAB MEMBRANE. UNDER MICROSCOPY, A SMOOTH & SQUARE EDGED PENETRATION WAS SEEN AT THE LEAK SITE. PROBABLE CAUSE OF DIFFICULTY: THE PHYSICAL EVIDENCE INDICATES THAT THE SOURCE OF THE BALLOON LEAK WAS A PENETRATION OF THE MEMBRANE, PROBABLY CAUSED BY CONTACT WITH A SHARP EDGED OBJECT. THE MEMBRANE DAMAGE MAY HAVE OCCURRED PRIOR TO OR DURING BALLOON INSERTION.

    Description of Event or Problem · 1

    THE IAB LEAKED DURING INSERTION. ON 06/10/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE DOCTOR PERFORMED CORONARY ARTERY BYPASS GRAFT SURGERY ON A 70 YEAR OLD PT WITH 100% LEFT MAIN LESION. PT HAD A HEMODYNAMIC COMPROMISE AFTER BIENG WEANED OFF CARDIOPULMONARY BYPASS, AND IT WAS DECIDED TO SUPPORT HIM ON IABP. THE DOCTOR INTRODUCED THE SHEATH BY SELDINGER TECHNIQUE INTO THE RIGHT FEMORAL ARTERY. WHEN THE BALLOON WAS INTRODUCED INTO THE SHEATH OVER THE GUIDE WIRE FOR JUST 2-4 INCHES, THE DOCTOR COULD SEE BLOOD INSIDE THE BALLOON. BLOOD WAS REGURGITATING INTO THE BALLOON. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. (MULTIPLE COMPLAINT). (EVENT COMPLICATIONS): UNKNOWN - REPORTED 05/15/1998; NONE - REPORTED 06/10/1998. (PT'S CURRENT STATUS): UNK -05/15/1998, 06/10/1998.

    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 03/25/99

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR