BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12319197 · Received August 13, 2021

    Report

    Report Number
    2029046-2021-01338
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    July 21, 2021
    Report Date
    July 22, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF # (B)(4) ON (B)(6) 2021, UPON AN INTERNAL REVIEW OF THE COMPLAINT RECORD IT WAS DETERMINED THAT THE BWI THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER SHOULD BE CONSIDERED A CONCOMITANT DEVICE IN THIS CASE AND THE SUSPECTED DEVICE SHOULD BE THE BOSTON SCIENTIFIC WATCHMAN DEVICE. SINCE IT IS CERTAINLY NOT UNHEARD OF FOR A TEAR IN THE LEFT ATRIAL APPENDAGE TO OCCUR WITH AN ABLATION CATHETER, IT IS MORE LIKELY RELATED TO A DEVICE IMPLANTATION SINCE THE LEFT ATRIAL APPENDAGE (LAA) IS OFTEN AVOIDED DURING ABLATIONS UNLESS ABSOLUTELY NECESSARY. IN THIS SCENARIO, WE HAVE A MOST LIKELY CANDIDATE IN THE LAAO DEVICE AND NOT THE ABLATION CATHETER. AS SUCH, THE EVENT WILL NO LONGER BE CONSIDERED TO BE MDR REPORTABLE AGAINST THE BIOSENSE WEBSTER INC. DEVICE.

    Additional Manufacturer Narrative · 1

    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 MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE ((B)(6) LBS) WITH A HISTORY OF A STROKE (CVA) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND WATCHMAN IMPLANTATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. POST OPERATION, FOLLOWING AN AFIB AND WATCHMAN IMPLANT PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THEY PERFORMED A PERICARDIOCENTESIS BUT WERE UNABLE TO STOP THE BLEEDING INTO THE PERICARDIAL SPACE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND WAS FOUND TO HAVE A TEAR IN THE ATRIAL APPENDAGE. THE TEAR WAS REPAIRED AND THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) FOR RECOVERY. THE REPORTER STATED THAT THE TEAR IS BELIEVED TO HAVE BEEN CAUSED BY THE WATCHMAN DEVICE. THIS ADVERSE EVENT DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT THE WATCHMAN IMPLANTATION CAUSED THE ADVERSE EVENT; THE PHYSICIAN WAS VERY CONFIDENT ABOUT THIS. INTERVENTION PROVIDED WAS A TAP & SURGICAL REPAIR. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. A TRANSSEPTAL PUNCTURE WAS PERFORMED. PRIOR TO NOTING THE CARDIAC TAMPONADE ABLATION WAS PERFORMED THERE WAS NO EVIDENCE OF STEAM POP. THE IRRIGATED CATHETER WAS USED IN THE EVENT WITH STANDARD/RECOMMENDED FLOW SETTINGS. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION FEATURES USED: GRAPH, DASHBOARD, VECTOR & VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY USE AT RECOMMENDED SETTINGS ¿ RANGE: 3, TIME 3, FORCE OVER TIME (FOT) OF 25% FOR 3G, TAG SIZE 3 AND FORCE TIME INTERVEL (FTI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218556 THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R CARTO 3 SYSTEM| UNKNOWN GENERATOR| UNKNOWN PUMP| CARTO 3 SYSTEM| UNKNOWN GENERATOR| UNKNOWN PUMP