BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER MULLINS GUIDING SHEATH

    MDR report key: 21784943 · Received April 7, 2025

    Report

    Report Number
    1820334-2025-00350
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 12, 2025
    Report Date
    August 7, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K171988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING A CARDIAC CASE INVOLVING A PATIENT WITH A PATENT DUCTUS ARTERIOSUS, A PERFORMER MULLINS GUIDING SHEATH BECAME TORN. PER THE REPORTER, THE USER ATTEMPTED TO USE THE SHEATH; HOWEVER, THE SHEATH KINKED AND WAS "UNABLE TO PASS THE DEVICE". REPORTEDLY, THE "DEPLOYMENT WIRE" CAME OUT OF THE SHEATH, FROM THE INSIDE TO OUTSIDE, TEARING THE "NECK PART" OF THE SHEATH. THE SHEATH WAS REMOVED IMMEDIATELY AND REPLACED WITH ANOTHER SHEATH 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE SHEATH WAS DAMAGED APPROXIMATELY 54.6-CENTIMETERS FROM THE HUB. THE SHEATH WAS ALSO PUNCTURED, BUT DID NOT LEAK DURING LEAK TESTING. THE DILATOR WAS NOT DAMAGED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE FINAL OR SUB-ASSEMBLY LOTS. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THE FINAL OR SUB-ASSEMBLY LOTS. THE PRODUCT IFU STATES ¿ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE INTRODUCER OR DILATOR. DAMAGE MAY RESULT WHEN FIT IS TIGHT.¿ THE IFU ALSO STATES ¿IF RESISTANCE IS ENCOUNTERED DURING MANIPULATION, STOP AND DETERMINE THE CAUSE BEFORE PROCEEDING ANY FURTHER.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE 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. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE, UNRELATED TO DESIGN OR MANUFACTURING, CONTRIBUTED TO THIS EVENT. THE CUSTOMER DID NOT RESPOND TO COOK¿S ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. 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 A CARDIAC CASE INVOLVING A PATIENT WITH A PATENT DUCTUS ARTERIOSUS, A PERFORMER MULLINS GUIDING SHEATH BECAME TORN. PER THE REPORTER, THE USER ATTEMPTED TO USE THE SHEATH; HOWEVER, THE SHEATH KINKED AND WAS "UNABLE TO PASS THE DEVICE". REPORTEDLY, THE "DEPLOYMENT WIRE" CAME OUT OF THE SHEATH, FROM THE INSIDE TO OUTSIDE, TEARING THE "NECK PART" OF THE SHEATH. THE SHEATH WAS REMOVED IMMEDIATELY AND REPLACED WITH ANOTHER SHEATH 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654324 PERFORMER MULLINS GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G07816 16138136

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female