BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINICAL INSTRUMENT

    MDR report key: 248485 · Received November 2, 1999

    Report

    Report Number
    MW1017468
    Event Type
    Injury
    Date Received
    November 2, 1999
    Date of Event
    October 5, 1999
    Report Date
    October 11, 1999
    Manufacturer
    CLINICAL INSTRUMENTS INTERNATIONAL, INC.
    Product Code
    MIR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT W/ LT CAROTID STENOSIS FOR SURGERY (ENDARTERECTOMY). SHUNT PLACED BY SURGEON AND APPROX 5-10 MINUTES LATER AIR NOTED AT DISTAL BALLOON SITE; CLAMPED AND REMOVED. THE PRODUCT WAS A REPLACEMENT FOR AN EXISTING PRODUCT USED W/ SAME CATALOG NUMBER. SURGEON DESCRIBES AS "INFERIOR". ADDITIONAL INFO RECEIVED FROM MFR 12/23/99: 1) FAILURE ANALYSIS: MFR IS UNABLE TO SECURE EITHER THE FAILED PART OR ANY DESCRIPTION OF THE DETAILS OF WHAT PART OF THE SHUNT FAILED. (BALLOON, BALLOON AT BOND OR CATHETER, SLICE, RIP SEPARATION OR OTHER). THE BALLOON IS TESTED TWO TIMES IN MFG, THEN A THIRD TEST IN QUALITY CONTROL. WHILE MFR HAS A SAMPLING LOT SIZE MFR, IN ACTUALITY TEST NOT ONLY THE BALLOON (AS MFR SHOWS IN PROCEDURE) AT 100%, BUT CHECKS ALL OTHER ASPECTS ALSO AT 100% RATE. WITHOUT THE PART, MFR SURMISES THE FOLLOWING POSSIBILITIES. A) THE CEMENT MFR HAD USED AT THE TIME THIS SHUNT WAS MANUFACTURED MAY BE SUBJECT TO SOME DETERIORATION IF EXPOSED TO HIGH HUMIDITY. THIS IS NOT IN THE LITERATURE, BUT MFR WAS SO TOLD VERBALLY BY A CEMENT SUPPLIER. MFR IS GOING TO ADD "DRY" TO COOL AND DARK IN PRECAUTIONS INSERT, IN ADDITION TO SUCH NOTATION THAT MFR DOES HAVE ON THE LABEL. IN REALITY THE INSERT IS NORMALLY SEEN AT TIME OF USE, BUT MFR WILL BE EXTRA CAUTIOUS. MFR CHANGED A PROCEDURE SUBSEQUENT TO THIS PART'S MANUFACTURE, FOR ESTHETIC REASONS, THAT ALSO HAS AS A BY-PRODUCT, CAPSULATING THE CEMENT WITH A DIFFERENT CEMENT, THUS FURTHER PROTECTING IT. B) THE BALLOON MATERIAL IS LATEX WHICH IS ORGANIC, AND SOME WEAKNESS MAY HAVE TAKEN TIME TO DEVELOP. MFR CAN LEARN THE PROFILE OF THE BREAK AS WELL AS ITS LOCATION ONLY FROM EITHER THE HOSPITAL OR EXAMINING THE ITEM. THE HOSPITAL DID NOT RESPOND TO EITHER REQUEST. C) THE LITERATURE ON THE PRACTITIONER PROCEDURE, MFR IS TOLD, NOTES THE PRACTITIONER MUST BE CAREFUL TO NOT IMPACT THE BALLOON WITH AN INSTRUMENT. CHANGES MFR WILL MAKE AS A RESULT OF THIS INCIDENT: WHILE THERE IS NO DEFINITIVE DATA ON THE EFFECT OF HUMIDITY MFR WILL ADD "DRY" TO THE COOL AND DARK ENVIRONMENTAL PRECAUTIONS IN ADDITION TO THE LABEL, WHERE IT NOW APPEARS. MFR'S TESTS ON RETAINED SAMPLES FROM THIS PRODUCTION LOT SHOWED RESULTS FAR BEYOND BURST SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL INSTRUMENT CAROTID SHUNT W/ LATEX BALLOON MIR CLINICAL INSTRUMENTS INTERNATIONAL, INC. 30LI LATEX 022098033 CSL

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization