BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 20866914 · Received December 6, 2024

    Report

    Report Number
    1820334-2024-01610
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 20, 2024
    Report Date
    May 22, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002480049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: CUSTOMER NAME AND ADDRESS = PHONE:(B)(6). G4: PMA/510(K) NUMBER = K240589. 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 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S ACCESS NEEDLE WAS LOOSE AT THE HUB. THE USER ATTEMPTED TO INSERT THE NEEDLE INTO THE FEMORAL ARTERY TO THE SUPERFICIAL FEMORAL ARTERY ONE TIME; HOWEVER, IT REPORTEDLY "DIDN'T WORK" AND RESISTANCE WAS ENCOUNTERED, SO THE NEEDLE WAS REPLACED WITH ANOTHER DEVICE OF THE SAME TYPE TO COMPLETE THE PROCEDURE. THE DEVICE PACKAGE WAS NOT DAMAGED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE AFFECTED COMPONENT IS SUPPLIED TO COOK FROM AN EXTERNAL SUPPLIER. THE SUPPLIER REVIEWED THEIR PRODUCTION PROCESS AND DETERMINED THE LOT REVIEW DOES NOT INDICATE ANY ISSUES THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THE SUPPLIER WAS UNABLE TO DETERMINE A ROOT CAUSE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT AND SUB ASSEMBLY LOTS. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. 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, AND IFU, SUGGESTS THAT THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, COOK HAS CONCLUDED THAT THIS IS AN ISOLATED INCIDENT AND THERE IS NO EVIDENCE OF ADDITIONAL NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED QUALITY CONTROL DEFICIENCY 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 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S ACCESS NEEDLE WAS LOOSE AT THE HUB. THE USER ATTEMPTED TO INSERT THE NEEDLE INTO THE FEMORAL ARTERY TO THE SUPERFICIAL FEMORAL ARTERY ONE TIME; HOWEVER, IT REPORTEDLY "DIDN'T WORK" AND RESISTANCE WAS ENCOUNTERED, SO THE NEEDLE WAS REPLACED WITH ANOTHER DEVICE OF THE SAME TYPE TO COMPLETE THE PROCEDURE. THE DEVICE PACKAGE WAS NOT DAMAGED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470979 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G48004 15505773 00827002480049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown