BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 6270627 · Received January 23, 2017

    Report

    Report Number
    1820334-2017-00033
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    August 18, 2016
    Report Date
    December 30, 2016
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002080249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, FUNCTIONAL TESTING AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: THE RETURNED USED COMPLAINT DEVICE WAS PHOTOGRAPHED AND EXAMINED. THE VISUAL INSPECTION OF THE RETURNED DEVICE REPORTED BIO-MATTER WAS PRESENT AND THE 14.0FR DILATOR WAS FULLY INSERTED INTO THE SHEATH. THE SHEATH WAS LEAK TESTED AND THE CUSTOMER COMPLAINT OF LEAKAGE FROM THE VALVE WAS CONFIRMED. DESTRUCTIVE TESTING WAS PERFORMED IN ORDER TO EXAMINE THE DISC. THE SILICONE DISC WAS NOTED TO BE TORN. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT DATA BASE SEARCH REVEALED THIS COMPLAINT TO BE THE SECOND REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 7013211. THIS WAS FROM THE SAME CUSTOMER, BUT FOR A DIFFERENT FAILURE ON THE SAME DEVICE. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. IT IS FEASIBLE THAT USER TECHNIQUE CAUSED THE SILICONE DISC TO BE TORN FROM THE DILATOR DUE TO BEING INSERTED THROUGH THE DISK OFF-CENTER OR AT AN ANGLE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, FUNCTIONAL TESTING AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: "THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED SHOULD BE DETERMINED TO ENSURE ITS PASSAGE THROUGH THE INTRODUCER. ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT. WHEN INSERTING, MANIPULATING OR WITHDRAWING A DEVICE THROUGH AN INTRODUCER ALWAYS MAINTAIN INTRODUCER POSITION." THE RETURNED USED COMPLAINT DEVICE WAS PHOTOGRAPHED AND EXAMINED. THE VISUAL INSPECTION OF THE RETURNED DEVICE REPORTED BIO-MATTER WAS PRESENT AND THE 14.0FR DILATOR WAS FULLY INSERTED INTO THE SHEATH. THE OTHER TWO DILATORS IN THE SET WERE SEALED, UNUSED, AND UNDAMAGED. THE SHEATH WAS LEAK TESTED AND THE CUSTOMER COMPLAINT OF LEAKAGE FROM THE VALVE WAS CONFIRMED. DESTRUCTIVE TESTING WAS PERFORMED IN ORDER TO EXAMINE THE DISC. THE SILICONE DISC WAS NOTED TO BE TORN. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT DATA BASE SEARCH REVEALED THIS COMPLAINT TO BE THE SECOND REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 7013214. THIS WAS FROM THE SAME CUSTOMER, BUT FOR A DIFFERENT FAILURE ON THE SAME DEVICE. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. IT IS FEASIBLE THAT USER TECHNIQUE CAUSED THE SILICONE DISC TO BE TORN FROM THE DILATOR DUE TO BEING INSERTED THROUGH THE DISK OFF-CENTER OR AT AN ANGLE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE THE INTRODUCER WAS ALLEGEDLY LEAKING AND BLOOD WAS RUNNING OUT ALONG THE WIRE. .A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54210 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC N/A 00827002080249

    Patients

    Seq Age Sex Outcome Treatment
    1