BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SMART TOUCH BIDIRECTIONAL SF.

    MDR report key: 17320956 · Received July 13, 2023

    Report

    Report Number
    2029046-2023-01507
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    April 7, 2023
    Report Date
    August 29, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 21-JUL-2023, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS 2 REPORTS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN UNKNOWN SMART TOUCH BIDIRECTIONAL SF. THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT. CONFIRMED LIST OF THE ALL COMPONENT USED DURING THE CASE (INCLUDED THE ONE BEFORE SWITCHING TO SMA SYSTEM): GENERATOR NGEN : (B)(6); CONSOLE NGEN : SN (B)(6) ;IRRIGATION PUMP NGEN : SN (B)(6) (SN ISN'T REGISTERED ON THE SYSTEM SO THE IP HAS BEEN OPENED UNDER UNRECOGNIZED SN); POWER SUPPLY NGEN : SN (B)(6); MONITOR NGEN : (B)(6); MONITOR STAND NGEN : SN (B)(6); PIU : SN (B)(6); GENERATOR SMA ; UNKNOWN SN (WILL BE PROVIDE VIA EMAIL). CATHETER USED: SMARTTOUCH SF CATHETER. OTHER CATHETERS COULD HAVE BEEN USED BUT WE DON'T HAVE MORE INFORMATION YET. IT WILL BE CONFIRMED VIA EMAIL TOO. IT WAS REPORTED THAT DURING THE PROCEDURE, WITH THE NGEN GENERATOR, THEY HAD A PROBLEM WITH THE VISUALIZATION OF THE CATHETER, WHICH WAS NEITHER VISUALIZED OR RECOGNIZED BY THE CARTO SYSTEM EVEN THOUGH IT WAS CONNECTED TO THE DONGLE LINKED TO THE PIU (PATIENT INTERFACE UNIT). TO TRY TO SOLVE THE PROBLEM, THEY CONNECTED THE CATHETER DIRECTLY TO THE PIU, BUT THIS DID NOT SOLVE THE PROBLEM. THEY ALSO TRIED TO CHANGE THE CATHETER CABLE AND THE CATHETER ITSELF BUT IT DID NOT SOLVE THE PROBLEM EITHER. AS SOLUTION, THEY SWITCHED TO THE SMA SYSTEM, WHICH WORKED PERFECTLY. PROCEDURE COMPLETED. NO PATIENT CONSEQUENCES DURING THE PROCEDURE, BUT IN THE DAYS FOLLOWING THE PROCEDURE, THE PATIENT SUFFERED A STROKE. NO DELAY. THE PROCEDURE WAS (B)(6) 2023. NO JUSTIFICATION HAS BEEN GIVEN YET TO KNOW WHY THE INCIDENT HAD NOT BEEN GIVEN TO BWI WITHIN 24 HOURS. IT WAS REPORTED THAT THE PATIENT HAS PARTIALLY RECOVERED BUT THEY DO NOT HAVE MORE INFORMATION. FSE TROUBLESHOOT REQUIRED. PRIORITY HIGH. ADDITIONAL INFORMATION- RELATED TO THE CASE (B)(4), THMCL SMTCH SF BID, TC, D-F, LOT UNK. IN FIRST TIME, THE NGEN : REF (B)(4),, SN (B)(6) (EQUIPMENT NGEN REPLACED SINCE BEGINNING OF JULY), THEN FOLLOWING THE PROCEDURE WITH THE SMARTABLATE: REF (B)(4),, SN (B)(6) THE ADVERSE EVENT OCCURRED ON (B)(6) 2023. IT WAS DISCOVERED AFTER THE PROCEDURE, THE DAYS THAT FOLLOWED. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS BWI PRODUCT MALFUNCTION: LINKED TO THE LOSS OF TIME DUE TO THE MALFUNCTION OF THE NGEN. CHANGE OF THE NGEN FOR THE SMARTABLE; PROCEDURE: ABLATION OF AF/TA WHICH WAS THE PATIENT'S 5TH ABLATION PROCEDURE. OUTCOME OF THE ADVERSE EVENT IS IMPROVED, THEY DO NOT HAVE DETAILED INFORMATION ON THE PATIENT'S CONDITION AT THIS TIME. THE PATIENT'S CONDITION WAS STABLE AND IMPROVING IN THE DAYS-WEEKS FOLLOWING THE STROKE. PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT, FOLLOWING THE STROKE. THERMOCOOL® SMARTTOUCH® SF CATHETER WAS USED. ALL FORCE VISUALIZATION FEATURES WERE USED. COLOR OPTIONS USED PROSPECTIVELY WAS FTI 25%; AVERAGE; FORCE MINIMUM 3 G; TIME MINIMUM 3 S; OTHER MAXIMUN DISTANCE CHANGE 4 MM; AI 350 400 NO EVIDENCE OF CHAR DURING THE PROCEDURE. NO EVIDENCE OF BLOOD THROMBUS / CLOT DURING THE PROCEDURE. CARTO FILE ALREADY TRANSFERRED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP SWITCHING WAS FROM "LOW" TO "HIGH" FLOW DURING ABLATION. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101044 UNKNOWN SMART TOUCH BIDIRECTIONAL SF. CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H| L CARTO 3 SYSTEM| NGEN RF PUMP| SMARTABLATE GENERATOR