BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 6530974 · Received April 28, 2017

    Report

    Report Number
    1820334-2017-00944
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    September 23, 2015
    Report Date
    June 29, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002106758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW OF THE REPORT. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT THIS REPORT SHOULD HAVE BEEN SUBMITTED AS A MALFUNCTION REPORT. IN THIS CASE, NO PATIENT INJURY OCCURRED; HOWEVER, THIS MAY BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF IT RECURRED. THE PRELIMINARY INVESTIGATION RESULTS HAVE BEEN SENT TODAY. WE WILL UPDATE LATER IF ANY FURTHER INFORMATION IS DETERMINED. INVESTIGATION - EVALUATION A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DRAWING, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND TRENDS WAS CONDUCTED DURING THE INVESTIGATION. ADDITIONALLY, A FUNCTIONAL AND VISUAL EXAMINATION OF UNUSED PRODUCT WAS PERFORMED. THREE USED DEVICES FROM LOT # 6135153 WERE LEAK TESTED AND CONFIRMED TO LEAK WHILE AN 0.035 WIRE GUIDE WAS IN PLACE. THE DEVICES ALL LEAKED FROM THE CENTER OF THE SILICONE DISC. ADDITIONAL UNUSED DEVICES WERE RETURNED FROM 6135153 (QUANTITY 10), 5964945 (QUANTITY 1), 6031801 (QUANTITY 6). DURING TESTING OF THOSE DEVICES, THEY WERE CONFIRMED FOR LEAKAGE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THERE ARE CONTROLS IN PLACE TO DETECT LEAKAGE WHILE IN THE MANUFACTURING PROCESS, AND THE VALVE IS 100% LEAK TESTED PER QUALITY CONTROL SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. MEASURES HAVE BEEN PREVIOUSLY CONDUCTED TO ADDRESS THIS FAILURE MODE. 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 : FUNCTIONAL TESTING OF RETURNED DEVICES FROM LOT # 6135153 WERE LEAK TESTED AND LEAKAGE WAS CONFIRMED (ASSOCIATED WITH FITTING). THE DEVICES ALL LEAKED FROM THE CENTER OF THE SILICONE DISC. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE WERE TEN REJECTS FOR THIS LOT DURING INTERNAL QUALITY CONTROL. IT IS LIKELY THAT MANUFACTURING ACTIVITIES MAY HAVE CONTRIBUTED TO THIS FAILURE. MEASURES HAVE BEEN CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AS STATED BY THE REPORTER: ON (B)(6) 2015 DURING THREE FISTULA GRAM CASES, TWO OF THE THREE COOK SHEATHS USED FROM THE SAME LOT LEAKED EXCESSIVELY. THE EVENT OCCURRED AFTER THE PHYSICIAN PULLED THE DILATOR OUT OF THE SHEATH OVER A .035 GLIDE WIRE (ANOTHER MANUFACTURER). THIS WOULD RESULT IN A STEADY DRIP AND THE USE OF ANOTHER SHEATH. NO HARM TO PATIENTS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311093 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC N/A 00827002106758

    Patients

    Seq Age Sex Outcome Treatment
    1