BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8553343 · Received April 25, 2019

    Report

    Report Number
    2029046-2019-03035
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 4, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835000566
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW, IT WAS DETERMINED THAT THE MANUFACTURING RECORD EVALUATION PROVIDED IN THE INITIAL 3500A (B)(4) WAS INCORRECT. THE INFORMATION PREVIOUSLY REPORTED WAS: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30152683M NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. HOWEVER, THE CORRECT INFORMATION IS: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30146786M NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER PC-000428538 HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE # PC-000428538.

    Additional Manufacturer Narrative · 0

    ON APRIL 26, 2019, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE DATE OF EVENT WAS ON (B)(6) 2019 AND THE DATE A JOHNSON & JOHNSON EMPLOYEE BECAME AWARE OF THE EVENT WAS (B)(6) 2019. THEREFORE, DATE OF EVENT HAS BEEN POPULATED WITH A DATE OF (B)(6) 2019 AND DATE OF THIS REPORT HAS BEEN POPULATED WITH A DATE OF APRIL 4, 2019. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED; THEREFORE, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30152683M NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. CONCOMITANT PRODUCTS: BIOSENSE WEBSTER, INC. PRODUCT - WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY, CATALOG #: D135304, LOT #: 30152683M; BIOSENSE WEBSTER, INC. PRODUCT - COOLFLOW TUBING SET, CATALOG #: CFT003, LOT #: CF4383275; BIOSENSE WEBSTER, INC. PRODUCT - CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES, CATALOG #: CREFP6, SERIAL #: (B)(4). MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CEREBROVASCULAR ACCIDENT (CVA) REQUIRING NO INTERVENTIONS BUT EXTENDED HOSPITALIZATION. THE PROCEDURE WAS CARRIED OUT AS USUAL AND HAD A PHASE OF MAPPING, ABLATION AND CARDIOVERSION. THE PATIENT WAS UNDER GENERAL ANESTHESIA. WHEN THE PATIENT WAS AWAKENED FROM THE ANESTHESIA, THE PHYSICIAN OBSERVED MUSCULAR NUMBNESS. THE PATIENT HAD DEVELOPED A CEREBRAL EMBOLISM. NO MEDICAL/SURGICAL INTERVENTION WAS PROVIDED; HOWEVER, EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PHYSICIAN WAS UNSURE ON WHETHER THE ADVERSE EVENT WAS RELATED TO THE PROCEDURE OR PATIENT¿S CONDITION. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343576 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC 30146786M 10846835000566

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L