BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 12548183 · Received September 29, 2021

    Report

    Report Number
    1820334-2021-02244
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 14, 2021
    Report Date
    January 17, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002089570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING AN IVC FILTER REMOVAL A PERFORMER INTRODUCER LEAKED FROM THE VALVE. ACCESS WAS GAINED FROM THE RIGHT INTERNAL JUGULAR VEIN. AS THE USER ADVANCED THE SHEATH THEY FOUND THE VALVE LEAKED. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. THE COMPLAINANT RETURNED ONE USED DEVICE TO COOK FOR INVESTIGATION. A LEAK TEST WAS PERFORMED AND A LEAK WAS CONFIRMED. TIP DAMAGE WAS ALSO NOTED TO THE SHEATH. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE INSTRUCTIONS FOR USE (IFU). THE FOLLOWING INFORMATION IS PROVIDED TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿UPON REMOVAL FROM PACKAGE, ENSURE THE INNER DIAMETER (ID) OF THE INTRODUCER IS APPROPRIATE FOR THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED.¿ ¿USING THE SIDE-ARM OF THE VALVE, FLUSH THE INTRODUCER BY FILLING THE INTRODUCER ASSEMBLY COMPLETELY WITH HEPARINIZED SALINE.¿ HOW SUPPLIED ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: RT, COORDINATOR OF VASCULAR SERVICES. PMA/510K # K171999. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING AN IVC FILTER REMOVAL A PERFORMER INTRODUCER LEAKED FROM THE VALVE. ACCESS WAS GAINED FROM THE RIGHT INTERNAL JUGULAR VEIN. AS THE USER ADVANCED THE SHEATH THEY FOUND THE VALVE LEAKED. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443716 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G08957 13007861 00827002089570

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male