BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ WIRE GUIDE

    MDR report key: 17985101 · Received October 23, 2023

    Report

    Report Number
    1820334-2023-01418
    Event Type
    Injury
    Date Received
    October 23, 2023
    Report Date
    February 28, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: THE CUSTOMER NAME AND ADDRESS WAS NOT PROVIDED TO COOK. G4: PMA/510(K) NUMBER = ALTHOUGH THE LOT, RPN, AND GPN ARE UNKNOWN, THE 510(K) FOR COOK AMPLATZ J WIRES IS K171764. 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 VIA A MEDWATCH REPORT, DURING AN ELECTROPORATION PROCEDURE FOR TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION, USING ANOTHER MANUFACTURER'S ABLATION DEVICE, AN UNSPECIFIED COOK AMPLATZ 0.035-INCH J WIRE GUIDE WAS USED. THE LEFT PULMONARY VEINS WERE ABLATED BUT POSITIONING OF THE WIRE GUIDE IN THE RIGHT INFERIOR PULMONARY VEIN AND DEPLOYMENT OF THE CATHETER TO "BASKET SHAPE" WAS DIFFICULT DUE TO THE PATIENT'S ANATOMY. RESISTANCE WAS ENCOUNTERED AND THE WIRE REPORTEDLY STUCK WITHIN THE CATHETER; HOWEVER, BY PUSHING THE WIRE SLOWLY, THE WIRE AND CATHETER WERE REMOVED FROM THE PATIENT. THERE WERE NO ISSUES FOUND ON THE CATHETER, BUT THE WIRE GUIDE WAS DAMAGED. THE WIRE GUIDE WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. AT THE END OF THE PROCEDURE, A "SMALL" CARDIAC TAMPONADE WAS NOTED. THE TAMPONADE WAS TREATED/STOPPED WITH DRAINAGE, AND PROTAMINE WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT IS EXPECTED TO FULLY RECOVER. CORRECTED INFORMATION: H6 (ANNEX A) INVESTIGATION EVALUATION: REVIEWS OF DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER IS UNKNOWN, AND CUSTOMER CONTACT INFORMATION WAS NOT PROVIDED IN THE MEDWATCH REPORT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES ¿DO NOT ADVANCE OR WITHDRAW A WIRE GUIDE WHEN RESISTANCE IS ENCOUNTERED, AS A PERFORATION COULD OCCUR.¿ 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 AND IFU 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 ANATOMY AND PROCEDURAL ISSUES LIKELY CONTRIBUTED TO THIS EVENT. THE USER REPORTED DIFFICULTY PLACING THE WIRE AND OTHER MANUFACTURER¿S ABLATION CATHETER AND ALSO REPORTED RESISTANCE WHEN REMOVING THE DEVICES, FINDING WIRE DAMAGE AFTER REMOVAL. ALTHOUGH IT IS POSSIBLE THAT THE DEVICES CONTRIBUTED TO CARDIAC TAMPONADE, THIS CANNOT BE DEFINITIVELY DETERMINED. 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 VIA A MEDWATCH REPORT, DURING AN ELECTROPORATION PROCEDURE FOR TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION, USING ANOTHER MANUFACTURER'S ABLATION DEVICE, AN UNSPECIFIED COOK AMPLATZ 0.035-INCH J WIRE GUIDE WAS USED. THE LEFT PULMONARY VEINS WERE ABLATED, BUT POSITIONING OF THE WIRE GUIDE IN THE RIGHT INFERIOR PULMONARY VEIN AND DEPLOYMENT OF THE CATHETER TO "BASKET SHAPE" WAS DIFFICULT DUE TO THE PATIENT'S ANATOMY. RESISTANCE WAS ENCOUNTERED AND THE WIRE REPORTEDLY STUCK WITHIN THE CATHETER; HOWEVER, BY PUSHING THE WIRE SLOWLY, THE WIRE AND CATHETER WERE REMOVED FROM THE PATIENT. THERE WERE NO ISSUES FOUND ON THE CATHETER, BUT THE WIRE GUIDE WAS DAMAGED. THE WIRE GUIDE WAS REPLACED AND THE PROCEDURE WAS CONTINUED. AT THE END OF THE PROCEDURE, A "SMALL" CARDIAC TAMPONADE WAS NOTED. THE TAMPONADE WAS TREATED/STOPPED WITH DRAINAGE, AND PROTAMINE WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

    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
    2125263 AMPLATZ WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R BSC FARAWAVE PULSED FIELD ABLATION CATHETER