BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 13961805 · Received March 31, 2022

    Report

    Report Number
    2029046-2022-00687
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    February 25, 2022
    Report Date
    August 18, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009002
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 21-JUN-2022, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE PATIENT, PRODUCT AND EVENT. IT WAS REPORTED THE PATIENT WAS A MALE, WEIGHING 116 KG AND WITH A DATE OF BIRTH OF 7-MAR-1949. NO RELEVANT PATIENT HISTORICAL INFORMATION IS AVAILABLE; NO RELEVANT TEST RESULTS OR LABORATORY DATA IS AVAILABLE. IT WAS CLARIFIED THAT THE PRODUCT CODE OF THE CATHETER USED WAS A D133602 (THMCL SMARTTOUCH,TC,F,C3) WHICH HAS BEEN UPDATED FROM UNK_SMART TOUCH BIDIRECTIONAL. AS SUCH, FIELDS D1. BRAND NAME HAS BEEN UPDATED FROM ¿THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER¿ TO ¿THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER¿. FIELD D4. CATALOG HAS BEEN UPDATED FROM ¿UNK_SMART TOUCH BIDIRECTIONAL¿ TO ¿D133602¿. THE EVENT DATE WAS ALSO UPDATED FROM 1-MAR-2022 TO 25-FEB-2022. FIELD B3. DATE OF EVENT, HAS BEEN UPDATED. IT WAS ALSO REPORTED IT WAS A COOLFLOW PUMP THAT WAS USED DURING THE PROCEDURE AND ENCOUNTERED A BUBBLE ERROR. HOWEVER, THE COOLFLOW PUMP COULD BE USED AFTER FLUSHING SEVERAL TIMES SO ABLATION COULD BE PERFORMED. THERE WAS EVIDENCE OF CHAR DURING THE PROCEDURE. THERE WAS NO EVIDENCE OF BLOOD THROMBUS / CLOT DURING THE PROCEDURE. CHAR IS A PHYSICAL PHENOMENON OF RADIOFREQUENCY ABLATION AND CAN BE A NORMAL RESULT OF THE ABLATION PROCESS. THE PRESENCE OF CHAR DOES NOT BY ITSELF REPRESENT A SERIOUS INJURY, NOR IS IT NECESSARILY THE RESULT OF A DEVICE MALFUNCTION. AS SUCH, CHAR IS NOT MDR REPORTABLE. IT WAS REPORTED THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS BWI PRODUCT MALFUNCTION. THE PATIENT RECEIVED A NEUROLOGICAL EVALUATION AS INTERVENTION. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED (NO RESIDUAL EFFECTS) AND DID NOT REQUIRE EXTENDED HOSPITALIZATION. A SMARTABLATE GENERATOR WAS USED DURING THIS CARE. THE VISITAG MODULE PARAMETERS FOR STABILITY USED WERE RANGE: 2MM, TIME: 3SEC, FORCE OVER TIME (FOT) 25% AND 3G MINIMUM FORCE WITH ABLATION INDEX (LOW 300 HIGH 450). THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE SMARTABLATE GENERATOR AND THE COOLFLOW PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. DEVICE EVALUATION DETAILS: ON 21, JUN-2022, THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE 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 REF. #(B)(4).

    Additional Manufacturer Narrative · 0

    ON 21-JUL-2022, ADDITIONAL INFORMATION WAS RECEIVED INDICATING A SMARTABLATE GENERATOR WAS USED IN THE CASE; IT HAS BEEN ADDED TO THE CONCOMITANT PRODUCT SECTION. ADDITIONALLY, BASED ON INFORMATION RECEIVED, IT¿S BEEN CONCLUDED THE PUMP USED DURING THE CASE WAS A SMARTABLATE PUMP AND NOT A COOLFLOW PUMP AS PREVIOUSLY REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4) CORRECTION: ON 18(B)(6) 2022, IT WAS NOTICED THE COOLFLOW PUMP AND CARTO 3 SYSTEM WERE INADVERTENTLY OMITTED FROM SECTION D10. CONCOMITANT MED PRODUCTS OF THE 3500A SUPPLEMENTAL MEDWATCH, FOLLOW UP #1. THEY HAVE NOW BEEN ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT. AFTER THE ATRIAL FIBRILLATION (AFIB) ABLATION THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT (CVA). IT WAS A TRANSIENT ACCIDENT AND THE PATIENT WILL BE FOLLOWED. THE SMARTABLATE PUMP GAVE MANY BUBBLE ALARMS AT THE START OF ABLATION, FLUSHING SEVERAL TIMES IN BETWEEN ABLATIONS SOLVED THE ISSUE AND ABLATION COULD BE CONTINUED WITHOUT BUBBLE ALARM. THE PUMP HAD RETURNED FROM A PREVENTIVE MAINTENANCE 1 WEEK BEFORE THIS PROCEDURE. THERE WAS A PROCEDURAL DELAY OF 10 MINUTES. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189949 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D133602 10846835009002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| L CARTO 3 SYSTEM.| SMARTABLATE GENERATOR KIT-WW.| SMARTABLATE PUMP KIT-WW.| UNK_COOLFLOW PUMP.