BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 15148381 · Received August 2, 2022

    Report

    Report Number
    1820334-2022-01301
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    June 17, 2022
    Report Date
    October 7, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002089570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER NAME AND ADDRESS= PHONE: (B)(6). PMA/510(K) NUMBER = K171999. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER'S SILICONE VALVE DISLODGED AND LEAKED BLOOD. PER THE REPORTER, THIS INCREASED THE RISK OF BLEEDING/HEMORRHAGE; HOWEVER, THERE HAS BEEN NO REPORT OF HEMORRHAGE AND NO REPORT THAT ANY INTERVENTION WAS REQUIRED TO TREAT BLOOD LOSS. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU CAUTIONS THAT ALL INSTRUMENTS OR CATHETERS USED WITH THE PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH, AND THAT DAMAGE TO THE VALVE OR INTRODUCER MAY RESULT IF THE FIT IS TIGHT. THE IFU INSTRUCTS THE USER TO INSPECT THE PRODUCT UPON REMOVAL FROM THE PACKAGE, AND ALSO STATES ¿WHEN INSERTING, MANIPULATING OR WITHDRAWING A DEVICE THROUGH AN INTRODUCER ALWAYS MAINTAIN INTRODUCER POSITION.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE, UNRELATED TO THE DESIGN OR MANUFACTURING OF THE COMPLAINT DEVICE, CONTRIBUTED TO THIS INCIDENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. 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

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER'S SILICONE VALVE DISLODGED AND LEAKED BLOOD. PER THE REPORTER, THIS INCREASED THE RISK OF BLEEDING/HEMORRHAGE; HOWEVER, THERE HAS BEEN NO REPORT OF HEMORRHAGE AND NO REPORT THAT ANY INTERVENTION WAS REQUIRED TO TREAT BLOOD LOSS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032691 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G08957 14640971 00827002089570

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown