BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 15307546 · Received August 26, 2022

    Report

    Report Number
    2029046-2022-02006
    Event Type
    Injury
    Date Received
    August 26, 2022
    Report Date
    August 26, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO: PC- (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BAI JIAN, WANG SHAOXIAN, ZHENG JIA, LI XIAOHONG, CHEN ZHENG, SHENG WENZHI, LIU YU, GU RONG, MA DONGHUI, XU WEI. EFFICACY OF RADIOFREQUENCY ABALATION AND CRYOBALLOON ABLATION FOR PAROXYMAL ATRIAL FIBRILLATION. TRANSLATED CHINESE PUBLISHED ARTICLE. DOI, PUBLISHER AND PUBLISHED DATE IS UNKNOWN. 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 NOT PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BAI JIAN, WANG SHAOXIAN, ZHENG JIA, LI XIAOHONG, CHEN ZHENG, SHENG WENZHI, LIU YU, GU RONG, MA DONGHUI, XU WEI. EFFICACY OF RADIOFREQUENCY ABALATION AND CRYOBALLOON ABLATION FOR PAROXYMAL ATRIAL FIBRILLATION. TRANSLATED CHINESE PUBLISHED ARTICLE. DOI, PUBLISHER AND PUBLISHED DATE IS UNKNOWN. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF RADIOFREQUENCY ABLATION AND CRYOBALLON ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION (AF) . THE STUDY WAS A RETROSPECTIVE STUDY WHERE PATIENTS WITH AF WHO UNDERWENT RADIOFREQUENCY ABLATION OR CRYOBALLON ABLATION FOR THE FIRST TIME IN NANJING DRUM TOWER HOSPITAL FROM SEPTEMBER 2014 TO OCTOBER 2018 WERE CONSECUTIVELY ENROLLED.ABLATION CATHETER WAS DIVIDED INTO COMMON CATHETER GROUP (GROUP A) AND CONTACT FORCE CATHETER GROUP (GROUP B); PATIENTS UNDERGOING CRYOBALLOON ABLATION WERE DIVIDED INTO FIRST-GENERATION CRYOBALLOON GROUP (¢ GROUP) AND SECOND-GENERATION CRYOBALLOON GROUP (GROUP D) ACCORDING TO WHETHER THE FIRST-GENERATION OR SECOND-GENERATION CRYOBALLOON WAS USED DURING SURGERY.DURING CRYOABLATION OF THE RIGHT SUPERIOR AND INFERIOR PULMONARY VEINS, SYNCHRONOUS PHRENIC NERVE PACING WAS GIVEN TO PREVENT PHRENIC NERVE PALSY. CRYOABLATION WAS STOPPED AS SOON AS DIAPHRAGMATIC MOTION DIMINISHED OR DISAPPEARED UNTIL DIAPHRAGMATIC MOTION RETURNED TO NORMAL. THERE WAS NO SIGNIFICANT DIFFERENCE IN SURGERY-RELATED DEATH, ISCHEMIC STROKE OR SHORT ISCHEMIC ATTACK (TA) VASCULAR COMPLICATIONS, CARDIAC TAMPONADE, PULMONARY VEIN STENOSIS, ESOPHAGOATRIAL FISTULA AND OTHER COMPLICATIONS AMONG THE FOUR GROUPS (ALL > 0.05); HOWEVER, THERE WAS SIGNIFICANT DIFFERENCE IN PHRENIC NERVE PARALYSIS SURGICAL COMPLICATIONS AMONG THE FOUR GROUPS (P < 0.05) . PHRENIC NERVE PARALYSIS OCCURRED IN PATIENTS A AND B2; 2 PATIENTS IN C HAD PHRENIC NERVE PARALYSIS AT DISCHARGE, OF WHICH 1 RECOVERED AT 6-MONTH FOLLOW-UP AFTER OPERATION; 1 PATIENT IN D HAD PHRENIC NERVE PARALYSIS AT DISCHARGE AND RECOVERED AT 6-MONTH FOLLOW-UP AFTER OPERATION.THE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO DETERMINE ACCURATE QUANTITIES OF THE ADVERSE EVENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH CONTACT FORCE CATHETER OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3, LASSO NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY (CRYOBALLOON GROUP): MARKER CATHETER (ACHIEVE, MEDTRONIC, USA) , FIRST- OR SECOND-GENERATION CRYOBALLOON (MEDTRONIC, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (ASSOCIATED WITH CONTACT FORCE GROUP): PHRENIC NERVE PARALYSIS, NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219050 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CARTO 3| FIRST- OR SECOND-GENERATION CRYOBALLOON (MEDT| LASSO| MARKER CATHETER (ACHIEVE, MEDTRONIC, USA)