BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 73083 · Received February 26, 1997

    Report

    Report Number
    2248146-1997-00105
    Event Type
    Malfunction
    Date Received
    February 26, 1997
    Date of Event
    January 17, 1997
    Report Date
    January 27, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED INFO INDICATED BY "UNK" WAS EITHER NOT SUPPLIED OR NOT KNOWN BY THE CONTACT EVEN AFTER MULTIPLE ATTEMPTS. THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON: 07/08/1997. EVALUATION SUMMARY: 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

    THE PT WAS RELATIVELY STABLE POST BYPASS SURGERY. FIVE MINUTES POST PROTAMINE ADMINISTRATION, THE PT BECAME HYPOTENSIVE AND AN IAB WAS PLACED VIA THE RIGHT FEMORAL ARTERY. WHEN THE BALLOON WAS HOOKED UP TO THE CONSOLE, BLOOD EXITED THE GAS PORT. THE BALLOON CATHETER WAS REMOVED AND A SECOND WAS INSERTED. ON 1/29/97, CO RECEIVED THE MANDATORY MEDWATCH FORM FROM THE DISTRIBUTOR. EVENT COMPLICATIONS: NONE FROM THE EVENT-REPORTED 1/27/97. PT'S CURRENT STATUS: UNK-RPT'D 1/27/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0269 08/31/98

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR