BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRD DEVICE, EMBOLIZATION, VASCULAR

    MDR report key: 17596385 · Received August 22, 2023

    Report

    Report Number
    1820334-2023-01128
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    August 16, 2023
    Report Date
    November 16, 2023
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION / EVALUATION: ON 16AUG2023, A REPRESENTATIVE FROM A HOSPITAL IN THE (B)(6) REPORTED THAT AN UNKNOWN EMBOLIZATION COIL MIGRATED TO THE HEART FROM THE SITE OF PLACEMENT IN THE UTERINE ARTERY. COMPETITOR COILS WERE ALSO USED DURING THE EMBOLIZATION PROCEDURE, BUT THE USER IS UNSURE WHICH MANUFACTURERS¿ COIL MIGRATED. THE PATIENT WAS REFERRED TO CARDIOLOGY AT A DIFFERENT HOSPITAL WHERE THE COIL WAS RETRIEVED. IT IS BELIEVED THE PATIENT DID WELL AFTER RETRIEVAL OF THE MIGRATED COIL. NO OTHER ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT THERE ARE SUFFICIENT INSPECTION ACTIVITIES IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED, DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. A REVIEW OF SALES RECORDS FOR THE CUSTOMER OVER A THREE-YEAR PERIOD PRIOR TO THE DATE OF EVENT WERE UNABLE TO NARROW DOWN A POSSIBLE LOT NUMBER. COOK WAS ABLE TO REVIEW PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [T_MWCER_REV6] STATE THE FOLLOWING: "WARNINGS: POSITIONING OF EMBOLIZATION COILS SHOULD BE DONE WITH PARTICULAR CARE. COILS SHOULD NOT BE LEFT TOO CLOSE TO THE INLETS OF ARTERIES AND SHOULD BE INTERMESHED WITH PREVIOUSLY PLACED COILS IF POSSIBLE. A MINIMAL BUT SUFFICIENT ARTERIAL BLOOD FLOW SHOULD REMAIN TO HOLD THE COILS AGAINST PREVIOUSLY PLACED COILS UNTIL A SOLID CLOT ENSURES PERMANENT FIXATION. THE PURPOSE OF THESE SUGGESTIONS IS TO MINIMIZE THE POSSIBILITY OF LOOSE COILS BECOMING DISLODGED AND OBSTRUCTING A NORMAL AND ESSENTIAL ARTERIAL CHANNEL. PRECAUTIONS: PERFORM AN ANGIOGRAM PRIOR TO EMBOLIZATION TO DETERMINE CORRECT CATHETER POSITION. THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN ARTERIAL AND VENOUS VESSEL EMBOLIZATION TECHNIQUES. STANDARD TECHNIQUES FOR PLACEMENT OF VASCULAR ACCESS SHEATHS, ANGIOGRAPHIC CATHETERS, AND WIRE GUIDES SHOULD BE EMPLOYED. COIL DELIVERY TECHNIQUE AND COIL SIZE SELECTION LONG-TERM OCCLUSION DEPENDS ON ACHIEVING CROSS SECTIONAL OCCLUSION OF THE BLOOD VESSEL, AND COAXIAL CATHETERS PROVIDE THE ABILITY TO CONTROL PLACEMENT OF COILS AND PERMANENT OCCLUSION. THE COMBINATION OF THE COAXIAL TECHNIQUE AND EITHER THE ANCHOR OR SCAFFOLD TECHNIQUE SIGNIFICANTLY ENHANCES STABILITY OF COIL DEPLOYMENT. IN GENERAL, THE FIRST COIL SELECTED SHOULD HAVE A DIAMETER THAT IS 20% LARGER, OR 2 MM OVERSIZED, THAN THE VESSEL THAT IS BEING OCCLUDED." EVIDENCE GATHERED UPON REVIEWS OF THE DMR 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, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. IT IS POSSIBLE THE COIL CHOICE WAS THE INCORRECT SIZE FOR THE VESSEL; HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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. CORRECTION: B1, B2, H1, H6 - ANNEX F. ADDITIONAL INFORMATION: B5, D. D. - SUSPECT MEDICAL DEVICE: THE IDENTITY OF THE COMPLAINT DEVICE REMAINS UNKNOWN. HOWEVER, ADDITIONAL INFORMATION RECEIVED INDICATED THE COMPLAINT DEVICE IS POSSIBLY A (B)(6), RETRACTA DETACHABLE EMBOLIZATION COIL. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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 OR UNAVAILABLE. E1 - CUSTOMER (PERSON): POSTAL CODE: (B)(6), PHONE:(B)(6), FAX: (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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. AS REPORTED, AFTER THE COIL MIGRATED, THE PATIENT WAS REFERRED TO CARDIOLOGY AT A DIFFERENT HOSPITAL WHERE THE COIL WAS RETRIEVED. IT WAS NOTED BY THE AREA REPRESENTATIVE THAT IT IS BELIEVED THAT THE PATIENT DID WELL AFTER RETRIEVAL OF THE MIGRATED COIL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN PATIENT PRESENTED TO ACCIDENT AND EMERGENCY (A&E) FOUR WEEKS AFTER UNDERGOING A UTERINE ARTERY EMBOLIZATION PROCEDURE. IT WAS SUSPECTED THAT AN UNKNOWN COOK COIL MIGRATED TO THE HEART FROM THE SITE OF PLACEMENT IN THE UTERINE ARTERY. IT SHOULD BE NOTED THAT COMPETITOR COILS WERE ALSO USED DURING THE EMBOLIZATION PROCEDURE, AND THE PHYSICIAN IS UNSURE WHICH MANUFACTURER'S COIL MIGRATED. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME AND EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271561 KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention UNKNOWN BOSTON SCIENTIFIC COIL.