BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 20614195 · Received November 5, 2024

    Report

    Report Number
    1820334-2024-01458
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    October 17, 2024
    Report Date
    May 8, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002480032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION = LAB MANAGER. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS ORIGINALLY REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S DILATOR SEPARATED UPON REMOVAL. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE NEEDLE WAS INSERTED, FOLLOWED BY THE WIRE GUIDE. THE NEEDLE WAS THEN REMOVED, AND THE DILATOR AND SHEATH WERE INSERTED OVER THE WIRE. WHEN THE USER REMOVED THE DILATOR, THE HUB SEPARATED AS THE DILATOR WAS PULLED FROM THE PATIENT, AND THE DILATOR SHAFT WAS "LOST" INSIDE THE PATIENT'S BODY IN THE "GROIN AREA." THE PATIENT REPORTEDLY HAD TO GO INTO SURGERY IN ORDER FOR THE PHYSICIANS TO LOOK FOR THE BROKEN DILATOR. ADDITIONAL INFORMATION WAS RECEIVED 06NOV2024. THE PROCEDURE WAS A DIAGNOSTIC ANGIOGRAM VIA ULTRASOUND-GUIDED ACCESS, AND THE ACCESS SITE WAS CALCIFIED. ALTHOUGH THE PATIENT WAS SENT TO SURGERY FOR ATTEMPTED REMOVAL OF THE DEVICE, THE SEPARATED SHAFT WAS NOT SUCCESSFULLY REMOVED. REPORTEDLY, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS EVENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 11NOV2024, THE OUTER SHEATH/CANNULA SHAFT WAS SEPARATED, APPROXIMATELY ONE-CENTIMETER FROM THE HUB. 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 OUTER SHEATH/CATHETER WAS SEPARATED APPROXIMATELY ONE-CENTIMETER FROM THE HUB. THE DISTAL PORTION WAS NOT RETURNED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES ¿DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT.¿ 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 THE PATIENT¿S CALCIFIED ANATOMY LIKELY CONTRIBUTED TO THIS EVENT. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B2, B5, D9, H6 (ANNEX E) CORRECTED INFORMATION: H6 (ANNEXES A & G) H3: DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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.

    Description of Event or Problem · 0

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S DILATOR SEPARATED UPON REMOVAL. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE NEEDLE WAS INSERTED, FOLLOWED BY THE WIRE GUIDE. THE NEEDLE WAS THEN REMOVED, AND THE DILATOR AND SHEATH WERE INSERTED OVER THE WIRE. WHEN THE USER REMOVED THE DILATOR, THE HUB SEPARATED AS THE DILATOR WAS PULLED FROM THE PATIENT, AND THE DILATOR SHAFT WAS "LOST" INSIDE THE PATIENT'S BODY IN THE "GROIN AREA." THE PATIENT REPORTEDLY HAD TO GO INTO SURGERY IN ORDER FOR THE PHYSICIANS TO LOOK FOR THE BROKEN DILATOR. THE OUTCOME IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2024. THE PROCEDURE WAS A DIAGNOSTIC ANGIOGRAM VIA ULTRASOUND-GUIDED ACCESS, AND THE ACCESS SITE WAS CALCIFIED. ALTHOUGH THE PATIENT WAS SENT TO SURGERY FOR ATTEMPTED REMOVAL OF THE DEVICE, THE SEPARATED SHAFT WAS NOT SUCCESSFULLY REMOVED. REPORTEDLY, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS EVENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 11NOV2024, THE OUTER SHEATH/CANNULA SHAFT WAS SEPARATED, APPROXIMATELY ONE-CENTIMETER FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999104 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G48003 16225365 00827002480032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O