BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 16522842 · Received March 10, 2023

    Report

    Report Number
    1820334-2023-00249
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 8, 2023
    Report Date
    July 28, 2023
    Manufacturer
    COOK VASCULAR INC
    Product Code
    KRD
    UDI-DI
    10827002342009
    PMA / PMN Number
    K151676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INITIAL REPORTER CUSTOMER (PERSON) ADDITIONAL DATA: PHONE NUMBER: (B)(6), ADDITIONAL PHONE NUMBER: (B)(6). 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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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 UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION (B)(6)HOSPITAL ((B)(6)) INFORMED COOK ON 08MAR2023 OF AN EVENT THAT OCCURRED ON THE SAME DATE INVOLVING A RETRACTA DETACHABLE EMBOLIZATION COIL (RPN: MWCER-35-14-12; LOT: NS13855719). IT WAS REPORTED THAT THE COIL DID NOT DETACH FROM THE DELIVERY WIRE WHEN ATTEMPTING DEPLOYMENT. AFTER SEVERAL ATTEMPTS, THE COIL WAS RETRACTED BACK AND TAKEN OUT OF THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. COOK RECEIVED ONE DEVICE IN A USED CONDITION. THE COIL WAS STILL ATTACHED TO THE WIRE, AND WAS LODGED INSIDE THE HUB OF THE CANNULA. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT NS13855719 RECORDS NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [T_MWCER_REV5] PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "INSTRUCTIONS FOR USE... 6. UNDER FLUOROSCOPIC VISUALIZATION, SLOWLY ADVANCE THE DELIVERY WIRE UNTIL THE ENTIRE LENGTH OF THE COIL EXITS THE DISTAL END OF THE CATHETER. ENSURE THAT THE JUNCTION REMAINS POSITIONED JUST INSIDE THE CATHETER TIP. (FIG.5) NOTE: ADVANCING THE DELIVERY WIRE SLOWLY ALLOWS THE JUNCTION TO BE SEEN MORE EASILY AND REDUCES THE RISK OF DAMAGING IT. NOTE: IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING COIL ADVANCEMENT, DO NOT CONTINUE ADVANCING. RETRACT THE DELIVERY WIRE SLIGHTLY, THEN GENTLY RE-ADVANCE IT. IF THERE IS STILL SIGNIFICANT RESISTANCE, WITHDRAW THE DELIVERY WIRE FROM THE CATHETER AND TRY USING A NEW COIL WITH A SHORTER LENGTH. 8. IF THE COIL POSITION IS CORRECT, USE THE TORQUE DEVICE TO TURN THE DELIVERY WIRE COUNTERCLOCKWISE 8-10 TIMES, UNTIL COIL DETACHMENT CAN BE EITHER FELT OR VISUALIZED UNDER FLUOROSCOPY. NOTE: IT IS RECOMMENDED THAT THE JUNCTION REMAIN JUST INSIDE THE TIP OF THE CATHETER. " THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, AND IFU SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, VISUAL INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL COULD NOT BE DEPLOYED/DETACHED. ON (B)(6) 2023, DURING AN UNKNOWN PROCEDURE IN AN UNKNOWN PATIENT, THE RETRACTA COIL WAS FULLY PUSHED THROUGH THE CATHETER SYSTEM AND INTO THE TARGET VESSEL BUT COULD NOT BE DEPLOYED/DETACHED. AFTER SEVERAL ATTEMPTS, THE COIL WAS RETRACTED BACK AND TAKEN OUT OF THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IT CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 0

    IN ADDITIONAL INFORMATION RECEIVED ON 12MAR2023, IT WAS REPORTED THAT THE JUNCTION ZONE WAS ABOUT 2/3 OUT OF THE CATHETER WHEN ATTEMPTING TO DEPLOY. IT WAS RECOMMENDED TO THE USER TO PULL BACK A BIT AND TRY TO DEPLOY AGAIN, BUT THIS WAS DONE WITHOUT SUCCESS.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182138 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK VASCULAR INC N/A NS13855719 10827002342009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown C1 CATHETER.