BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDITECH

    MDR report key: 55820 · Received December 11, 1996

    Report

    Report Number
    55820
    Event Type
    Injury
    Date Received
    December 11, 1996
    Date of Event
    July 24, 1996
    Report Date
    November 22, 1996
    Manufacturer
    MEDITECH, INC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON CATHETER WAS IN A PT'S GRAFTED ARTERY AND WOULD NOT DEFLATE. THE PT WENT INTO VENTRICULAR TACHYCARDIA AND WAS SHOCKED SUCCESSFULLY; THE BALLOON FINALLY DEFLATED. CHARGE NURSE (CN) WAS WAITING FOR SOME REPLY FROM THE CO AND MORE INFO FROM DR #1. CN REALIZES NOW (11/96) THAT SHE SHOULD HAVE CALLED RISK MANAGEMENT IMMEDIATELY. UNFORTUNATELY, THE PRODUCT WAS DISCARDED AT THE TIME OF THE INCIDENT. AFTER CLINICAL REVIEW, INCLUDING CONSULTATION WITH PHYSICIAN #1, THE SITUATION DOES NOT APPEAR TO BE THE RESULT OF AN OPERATOR ERROR. PT EXPERIENCED NO NEGATIVE OUTCOME AS A RESULT OF THIS EVENT. THIS SITUATION HAS NOT OCCURRED IN THE PAST. ON 11/6/96 DR #2 HAD A SIMILAR INCIDENT WITH A BALLOON IN A RENAL ARTERY. THE BALLOON WAS THE SAME MODEL AS THE ONE INVOLVED ON 7/24, CALLED SYMMETRY. CN INFORMED THE MFR'S REP, WHO TOLD CN SHE HAD REPORTED IT TO CO. DR.#2'S CASE HAD NO UNTOWARD EFFECTS; THEY FINALLY DEFLATED THE BALLOON. THE PRODUCT WAS SAVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH Implant BALLOON ARTERIAL CATHETER LIT MEDITECH, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening