BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT-MICRO, BI-DIRECTIONAL, D-D CURVE, C3, SPLIT HANDLE

    MDR report key: 10583892 · Received September 24, 2020

    Report

    Report Number
    2029046-2020-01328
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    September 7, 2020
    Report Date
    September 7, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A FEMALE PATIENT WITH HISTORY OF WITH HYPERTENSION, PREVIOUS CTI ABLATION, PALPITATIONS AND SHORTNESS OF BREATH UNDERWENT CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH QDOT-MICRO, BI-DIRECTIONAL, D-D CURVE, C3, SPLIT HANDLE AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE ISSUE HAS BEEN OBSERVED DURING ABLATION, HENCE DURING THE USE. PHYSICIAN DOES NOT HAVE A SOLID OPINION, ON THE CAUSALITY OF THE EVENT HOWEVER PROCEDURE IS THE MOST LIKELY. THE PATIENT HAS BEEN DISCHARGED AFTER 3-4 DAYS. PATIENT HAD TO STAY IN HOSPITAL DUE TO PERICARDIAL EFFUSION, AND DRAINAGE. DEVICE INVESTIGATION DETAILS: THE DEVICE INVESTIGATION HAS BEEN COMPLETED WHICH INCLUDED A MANUFACTURING RECORD EVALUATION (MRE). THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30343702L AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WAS FOUND DURING THE REVIEW. STILL NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER¿S REF # (B)(4) CORRECTION - THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM SECTION H10. OF THE 3500A INITIAL MEDWATCH REPORT: "THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER 510(K)/PMA # P030031/S078."

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. INITIAL REPORTER PHONE: (B)(6). MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WITH HISTORY OF WITH HYPERTENSION, PREVIOUS CTI ABLATION, PALPITATIONS AND SHORTNESS OF BREATH UNDERWENT CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH QDOT-MICRO, BI-DIRECTIONAL, D-D CURVE, SPLIT HANDLE AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE PROCEDURE WAS A STANDARD PAROXYSMAL AF ABLATION, LEFT AND RIGHT WIDE AREA CIRCUMFERENTIAL ABLATION (WACA). DURING THE PROCEDURE THE PHYSICIAN HAS STOPPED ABLATION ON SUSPICION OF LOW BLOOD PRESSURE (59/40MMHG). ABLATION SETTINGS WERE 50W, 47C WITH NGEN GENERATOR AND CARTO V7 SYSTEM. THE PHYSICIAN HAS BEEN TRAINED ON THE CATHETER AND THE SYSTEM. DURING THE ABLATION SETS, NO SUSPICIOUS MOVEMENT HAS BEEN OBSERVED BY ME OR THE CONSULTANT EXCEPT BRIEFLY THE CONSULTANT HAS REACHED 45GR FORCE FOR 6 SECONDS ON POSTERIOR WALL DURING LEFT WACA ABLATION NO ECG CHANGE HAS BEEN OBSERVED. PRIOR TO THE EVENT, ACT WAS 600 DUE TO GIVEN HEPARIN, THEN DROPPED GRADUALLY TO 500 LEVEL, WHEN WE HAVE SUSPECTED TAMPONADE. ECHO HAS BEEN PERFORMED AND CONFIRMED TAMPONADE. PERICARDIAL KIT HAS BEEN PREPPED FOR DRAINAGE AND 1.7 LITERS OF BLOOD HAS BEEN DRAINED, BLOOD TRANSFUSION HAS BEEN PREPPED AND GIVEN. HEART RATE WAS CONSTANT AROUND 65BPM. TO CORRECT THE ACT, 100MG PROTAMINE AND 3000IU OPTIFLEX HAVE BEEN GIVEN. PATIENT WAS CONSCIOUS DURING THE PROCEDURE. FORTY FIVE MINUTES LATER THE HEART RATE WAS BACK TO 90 AND TEMPERATURE WAS 35.7C. DURING POST INCIDENCE BRIEFING, THE PHYSICIAN HAS MENTIONED ABOUT STEAM POP ON HIS LAST ABLATION, WHICH WAS SET FOR 50W AND 47C WITH 5G FORCE AS INDICATED BY THE STANDARD OPERATING PROCEDURE FOR THIS CATHETER. THE ABLATION SITE WAS INFERIOR TO LEFT SUPERIOR PULMONARY VEIN, ON THE POSSIBLE MITRAL LINE REGION. NO IMPEDANCE RISE HAS BEEN OBSERVED OR RECORDED. ECHO WAS INCONCLUSIVE ABOUT THE EXACT LOCATION AND THE SIZE OF THE TAMPONADE. THE PATIENT HAS NOT BEEN TRANSFERRED TO THEATRES AFTER WE HAVE LEFT AND OBSERVED IN RECOVERY. THE PHYSICIAN HAS FURTHER TRIED TO DRAIN BLOOD HOWEVER THERE WASN¿T MORE THAN 20ML BLOOD. AS OF MORNING (B)(6) 2020 THE PATIENT IS STABLE. THE ISSUE HAS BEEN OBSERVED DURING ABLATION, HENCE DURING THE USE. PHYSICIAN DOES NOT HAVE A SOLID OPINION, ON THE CAUSALITY OF THE EVENT HOWEVER PROCEDURE IS THE MOST LIKELY. THE PATIENT HAS BEEN DISCHARGED AFTER 3-4 DAYS. PATIENT HAD TO STAY IN HOSPITAL DUE TO PERICARDIAL EFFUSION, AND DRAINAGE. DASHBOARD, VISITAG, VECTOR HAVE BEEN USED. VISITAG SETTINGS WERE PER STANDARD CLOSE PROTOCOL, 3MM, 3S, 3G FORCE ABOVE 25%. NO ADDITIONAL FILTER USED. ABLATION INDEX/SURPOINT WAS USED FOR COLOR OPTION. TRANSSEPTAL WAS PERFORMED WITH ABBOTT BRK NEEDLE. STANDARD SETTINGS WERE USED FOR IRRIGATION. THERE WAS NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045395 QDOT-MICRO, BI-DIRECTIONAL, D-D CURVE, C3, SPLIT HANDLE SIMILAR DEVICE D134801, PMA # P030031/S078 DRF BIOSENSE WEBSTER INC 30343702L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L ABBOTT BRK NEEDLE| CARTO V7 SYSTEM| NGEN RF GENERATOR