BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 5125152 · Received October 2, 2015

    Report

    Report Number
    1820334-2015-00675
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 23, 2015
    Report Date
    April 28, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: A REVIEW OF THE COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC), TRENDS, FUNCTIONAL TESTING AND A VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICES WERE CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. THREE USED DEVICES FROM LOT # 6099919 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. THERE ARE CONTROLS IN PLACE TO DETECT LEAKAGE WHILE IN THE MANUFACTURING PROCESS. THIS VALVE IS 100% LEAK TESTED PER QUALITY CONTROL SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED PER SPECIFICATIONS. MEASURES HAVE BEEN PREVIOUSLY TAKEN TO ADDRESS THIS ISSUE. THE RISK TO PATIENT WAS DETERMINED TO BE LOW BASED ON THE HEALTH RISK ASSESSMENT. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    IN ADDITION TO THE 3 SAMPLES OF LOT 6099919 WHICH WERE RETURNED IN A USED STATE, THE FOLLOWING UNUSED SAMPLES WERE ALSO RECEIVED AND EVALUATED: 6099919 (QUANTITY: 7), 5890374 (QUANTITY 2), 5985440 (QUANTITY 1), AND 6091901 (QUANTITY 3). THE LEAK CONDITION WAS CONFIRMED IN ALL RETURNED LOTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    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.

    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
    652981 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other