BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 13050548 · Received December 21, 2021

    Report

    Report Number
    2029046-2021-02236
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    November 30, 2021
    Report Date
    February 17, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 30-DEC-2021 UPDATING THE CONCOMITANT PRODUCT FROM A UNK_LASSO NAV ECO TO LASSO® 2515 NAV VARIABLE CATHETER. THEREFORE, UPDATED THE D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES FIELD. 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

    THE INVESTIGATION WAS COMPLETED ON 31-JAN-2022. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. 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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN (B)(6)-YEAR-OLD FEMALE ((B)(6)) PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND A LASSO® NAV ECO CATHETER. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND ECHOCARDIOGRAM (ECHO) AND THE EFFUSION WAS 1 CM IN THE VENTRICLE. MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 300CC OF FLUID WERE REMOVED AND THE EFFUSION WENT AWAY IMMEDIATELY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION BACK TO BASE LINE. THE PHYSICIAN STATED THAT THEY NEVER WENT OVER 35 WATTS AND THEY NEVER HAD HIGH FORCE AND ONLY HAD 12 -15 GRAMS AND NO STEAM POP WAS NOTICED AND THEY NEVER WENT ABOVE 400 F PRIME ON THE POSTERIOR WALL. THE PATIENT DID HAVE A LARGE HEART BUT THE PHYSICIAN DOES NOT BELIEVE THE BIOSENSE WEBSTER, INC. ABLATION CATHETER CAUSED THE ISSUE. PATIENT OUTCOME OF THE ADVERSE EVENT: IMPROVED- PATIENT IS RECOVERING. WORSENED: EFFUSION CONTINUED TO DRAIN AFTER JP DRAIN WAS PLACED. PATIENT WAS SENT TO ICU BUT A COMPUTED TOMOGRAPHY (CT) SURGEON DECIDED IT WAS BEST FOR HIM TO TAKE A LOOK BASED ON HIS JUDGMENT OF RATE OF DRAINAGE. PATIENT WENT TO SURGERY AND A SMALL HOLE WAS FOUND IN THE LEFT ATRIAL APPENDAGE. PATIENT WAS SENT TO THE ICU POST-SURGERY, IS STABLE AND IS RECOVERING. RELEVANT HISTORY: PREVIOUS PVI (B)(6) 2019- CARTO. A DOUBLE TRANSEPTAL WAS PERFORMED WITH A VERSA CROSS- BAYLIS SHEATH AND NEEDLE. PRIOR TO NOTICING THE CT ABLATION WAS PERFORMED. THEY CHECKED THE VEINS WITH A LASSO CATHETER AND THEY WERE ISOLATED. RADIO FREQUENCY WAS ONLY USED ON THE POSTERIOR WALL, DRAWING A ROOF LINE AND INFERIOR (FLOOR LINE) TO ISOLATE THE POSTERIOR WALL. THE EVENT OCCURRED POST RADIO FREQUENCY ABLATION OF POSTERIOR WALL. AN IRRIGATED CATHETER WAS USED IN THE EVENT, WHAT WAS THE FLOW SETTING: THERMOCOOL SF PLATFORM. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. VISITAG MODULE PARAMETERS FOR STABILITY WERE USED: 2 MM, 3 SECS, 25%, 3 GRAMS. NO ADDITIONAL FILTER USED WITH THE VISITAG. COLOR OPTIONS USED PROSPECTIVELY: OTHER. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE REPORTER SPOKE WITH THE PHYSICIAN AND SHE RELAYED THAT THE PATIENT HAD A SMALL TEAR IN HER LEFT ATRIAL APPENDAGE (LAA) THAT WAS FIXED IN SURGERY AND THAT THE PATIENT WAS STILL IN THE HOSPITAL AS OF (B)(6) 2021. THE PATIENT IS REPORTED TO BE STABLE AND RECOVERING APPROPRIATELY. THE REPORTER ALSO STATES THAT THE PHYSICIAN EXPRESSED THAT SHE BELIEVES THAT IT WAS THE LASSO CATHETER THAT CAUSED THE PERFORATION OF THE LAA. SHE SAID SHE REMEMBERS FEELING A LITTLE TENSION ON THE CATHETER AND THEN GENTLY REMOVED IT. SHE SAID THAT THE CT SURGEON DID SAY THAT THE LAA WAS VERY FRAGILE TO THE TOUCH. THIS EVENT WILL BE REPORTED UNDER BOTH THE ABLATION CATHETER (THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER) AND THE LASSO® NAV ECO CATHETER. THE LASSO® NAV ECO CATHETER WILL BE CONSERVATIVELY REPORTED IN THIS EVENT AS IT IS MENTIONED IN THE REPORT THAT THE PHYSICIAN BELIEVES THAT IT WAS THE LASSO® NAV ECO CATHETER THAT CAUSED THE PERFORATION OF THE LAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952172 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134702 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Hospitalization| R| L 7FR LASSO 2515 NAV VARI, 12P| NON BWI-VERSA CROSS-BAYLIS NEEDLE| NON BWI-VERSA CROSS-BAYLIS SHEATH| UNKNOWN BRAND GENERATOR| UNKNOWN BRAND PUMP| UNK_CARTO 3| UNK_LASSO NAV ECO