BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR GUIDING SHEATH

    MDR report key: 9711114 · Received February 14, 2020

    Report

    Report Number
    1820334-2020-00352
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 29, 2020
    Report Date
    April 30, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002322332
    PMA / PMN Number
    K142829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING A LIVER BIOPSY VIA TRANSJUGULAR ACCESS, THE HUB OF A FLEXOR GUIDING SHEATH LEAKED. AN UNKNOWN WIRE WAS IN THE LUMEN OF THE DEVICE AT THE TIME THE LEAK OCCURRED. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. 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. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION, AS WELL AS A VISUAL INSPECTION FUNCTIONAL TEST OF THE COMPLAINT DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION WITH BIOMATTER PRESENT. A LEAK TEST WAS PERFORMED, AND NO LEAK WAS DETECTED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO LOT RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. GIVEN THIS INFORMATION, THERE IS OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO COOK¿S SPECIFICATIONS. THE PRODUCT IFU STATES: ¿IN ORDER TO ENSURE DEVICE COMPATIBILITY, CHOOSE A SHEATH SIZE LARGE ENOUGH TO ACCOMMODATE THE MAXIMUM OUTER DIAMETER OF ANY DEVICES THAT WILL BE PLACED THROUGH THE SHEATH. ALL INTERVENTIONAL OR DIAGNOSTIC INSTRUMENTS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH TO AVOID LEAKAGE.¿ THE QUALITY CONTROL, MANUFACTURING, AND WORK INSTRUCTIONS CONTAIN ADEQUATE MEASURES TO ADDRESS THE FAILURE MODE PRIOR TO DISTRIBUTION. THERE WERE NO GAPS IDENTIFIED IN THE MANUFACTURING OR QUALITY CONTROL PROCESSES. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THIS EVENT CANNOT BE TRACED TO THE DEVICE, AS THE REPORTED FAILURE WAS UNABLE TO BE CONFIRMED. NO LEAK WAS NOTED DURING TESTING OF THE DEVICE. IT IS POSSIBLE THAT USER ISSUES OR DEVICE INTERACTION WITH THE WIRE GUIDE THAT WAS USED MAY HAVE PLAYED A ROLE IN THIS FAILURE; HOWEVER, THIS CANNOT BE CONFIRMED. RISK WAS ASSESSED FOR THIS COMPLAINT EVENT. NO RISK ESCALATION ACTIVITIES ARE RECOMMENDED AT THIS TIME. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K142829. 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 A LIVER BIOPSY VIA TRANSJUGULAR ACCESS, THE HUB OF A FLEXOR GUIDING SHEATH LEAKED. AN UNKNOWN WIRE WAS IN THE LUMEN OF THE DEVICE AT THE TIME THE LEAK OCCURRED. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. 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
    174267 FLEXOR GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G32233 10160377 00827002322332

    Patients

    Seq Age Sex Outcome Treatment
    1