BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 15332119 · Received August 31, 2022

    Report

    Report Number
    2029046-2022-02059
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    August 3, 2022
    Report Date
    October 2, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30763041L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. INITIAL REPORTER PHONE: (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 5-SEP-2022, ADDITIONAL INFORMATION WAS RECEIVED INDICATING NO PROLONGED HOSPITALIZATION WAS REQUIRED AND THERE WAS NO PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. A SMARTABLATE GENERATOR WAS USED DURING THE CASE AND HAVE BEEN ADDED TO THE CONCOMITANT PRODUCT SECTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 72-YEAR-OLD FEMALE PATIENT (33KG, 141CM) UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS STUCK IN MECHANICAL MITRAL VALVE WHICH REQUIRED INTERVENTION WITH AN ABLATION CATHETER TO FREE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. ADDITIONALLY, THE PATIENT SUFFERED ATRIAL TACHYCARDIA (AT). DURING MAPPING BY USING PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE SPINE OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS TEMPORARILY STUCK ON THE MITRAL VALVE. THE PATIENT HAS THE MECHANICAL VALVE AFTER MVR. THIS OCCURRED 3 HOURS AFTER THE START OF THE CASE. WHEN THE DIRECTION OF THE VALVE ANNULUS AT 9:00 WAS MAPPING, ATRIAL TACHYCARDIA (AT) OCCURRED AT THAT TIME. THE PHYSICIAN DID NOT PULL IT OUT UNNECESSARILY WHEN THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER BECAME STUCK. UNDER THE FLUOROSCOPY, HE ADVANCED THE ABLATION CATHETER TO THE MECHANICAL VALVE AND RELEASED THE PRN AGAINST THE STUCK MECHANICAL VALVE. THE PRN THEN RELEASED FROM THE MECHANICAL VALVE AND THE SITUATION RESOLVED. SINCE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS INTACT IT WAS CONTINUED TO BE USED WITH FURTHER CAUTION, THE PROCEDURE WAS PERFORMED WITHOUT INCIDENT AND COMPLETED. AFTER THE CASE, IT WAS CONFIRMED WITH ECHO AS A PRECAUTION, AND ALSO IT WAS CONFIRMED THAT THERE WAS NO PROBLEM IN THE MOVEMENT OF THE MECHANICAL VALVE. THE PROCEDURE COMPLETED SUCCESSFULLY. AFTER THE CASE, THE OPERATING DOCTOR APOLOGIZED FOR THE OCCURRENCE OF THIS EVENT EVEN THOUGH HE WAS ALERTED FROM J & J ABOUT THE CONTRAINDICATION TO THE USE OF THE MECHANICAL VALVE PATIENT. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER TEMPORARILY WAS STUCK AT THE MECHANICAL VALVE, BUT IT CAME OFF IMMEDIATELY, AND THERE WAS NO INJURY TO THE PRODUCT. THERE WAS NO PROBLEM WITH MOVEMENT OF THE MECHANICAL VALVE IN THE ECHO TEST AFTER THE CASE. THEREFORE, THE DOCTOR JUDGED THAT THERE WAS NO IMPACT ON THE PATIENT. THE CASE WAS COMPLETED WITHOUT ANY PROBLEM AND THE PATIENT WAS DISCHARGED TO THE GENERAL WARD. THE PHYSICIAN KNEW THAT J & J HAS CALLED ATTENTION TO THE CONTRAINDICATIONS, BUT THE CASE WAS PERFORMED BY COMPARING THE PATIENT'S CONDITION AND THE IMPORTANCE OF PERFORMING THE PROCEDURE. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE. THE PATIENT HAS FULLY RECOVERED. THERE WAS NO RING, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2353562 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128211 30763041L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other SMARTABLATE GEN. KIT (JAPAN)| SOUNDSTAR ECO GE 8F CATHETER| THMCL SMTCH SF BID, TC, D-F