BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 16569488 · Received March 18, 2023

    Report

    Report Number
    2029046-2023-00572
    Event Type
    Injury
    Date Received
    March 18, 2023
    Date of Event
    February 28, 2021
    Report Date
    March 17, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LITERATURE ARTICLE FILE IS TOO LARGE TO ATTACH. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:¿INKOVEC M, JAN M, ANTOLIC B, KLEMEN L, PERNAT A. LONG-TERM OUTCOMES AFTER CATHETER ABLATION OF ATRIAL FIBRILLATION: SINGLE CENTRE EXPERIENCE. ZDRAVVESTN [INTERNET]. 28FEB.2021 [CITED 24FEB.2023];90(1-2):21-7. AVAILABLE FROM: HTTPS://VESTNIK.SZD.SI/INDEX.PHP/ZDRAVVEST/ARTICLE/VIEW/3148. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:¿INKOVEC M, JAN M, ANTOLIC B, KLEMEN L, PERNAT A. LONG-TERM OUTCOMES AFTER CATHETER ABLATION OF ATRIAL FIBRILLATION: SINGLE CENTRE EXPERIENCE. ZDRAVVESTN [INTERNET]. 28FEB.2021 [CITED 24FEB.2023];90(1-2):21-7. AVAILABLE FROM: HTTPS://VESTNIK.SZD.SI/INDEX.PHP/ZDRAVVEST/ARTICLE/VIEW/3148. ABSTRACT: BACKGROUND: CATHETER ABLATION HAS BEEN WIDELY ADOPTED FOR THE TREATMENT OF ATRIAL FIBRILLATION (AF). WE HAVE ALREADY REPORTED ON EARLY AND MID-TERM ABLATION OUTCOMES. OUR AIM IS TO REPORT ON LONG-TERM CLINICAL OUTCOMES. METHODS: WE PERFORMED A FOLLOW-UP ON ALL PATIENTS IN WHOM THE FIRST CATHETER ABLATION WAS PERFORMED BETWEEN 2003 AND 2009 DUE TO ANTIARRHYTHMIC DRUG-REFRACTORY PAROXYSMAL OR PERSISTENT AF. WE ALSO CONSIDERED ABLATION PROCEDURES FOR TYPICAL ATRIAL FLUTTER (AU) PERFORMED AFTER 1999. COMPLETE ELECTRICAL ISOLATION OF THE PULMONARY VEINS (PV) WAS THE PRIMARY ABLATION TARGET. THE FLUOROSCOPY AND LASSO-CATHETER GUIDED SEGMENTAL RADIOFREQUENCY ABLATION PROCEDURE WAS PERFORMED. FOR TYPICAL AU, CAVOTRICUSPIDAL ISTHMUS LINEAR ABLATION WAS PERFORMED. PATIENTS WERE FOLLOWED UP FOR AT LEAST 5 YEARS AFTER THE COMPLETE PV ISOLATION, UP TO A TELEPHONE CALL IN APRIL 2020, OR DEATH. THEY WERE CLASSIFIED AS: A) SUCCESSFUL, IN STABILE SINUS RHYTHM WITH UP TO 5-MINUTE MILD PALPITATIONS, WITHOUT REGULAR ANTIARRHYTHMIC DRUG (AAD) TREATMENT, B) PARTIALLY SUCCESSFUL, MAINLY IN SINUS RHYTHM WITH RARE AF/AU EPISODES UP TO ONCE A YEAR AND PERIODIC AAD TREATMENT, AND C) UNSUCCESSFUL, WITH FREQUENT AF/AU EPISODES DESPITE AAD OR WITH LONG-TERM PERSISTENT AF/AU. ABLATION DUE TO RECURRENT AF/AU WAS REPEATED ONLY AFTER A BLANKING OF PERIOD OF THREE MONTHS. RECURRENT AF/AU WAS DOCUMENTED WITH SERIAL ECGS OR HOLTER MONITORING. THE RESULTS WERE EVALUATED BY KAPLAN-MEIER ANALYSIS, T-TEST AND FISHER¿S TEST. P < 0.05 WAS CONSIDERED SIGNIFICANT. RESULTS: WE INCLUDED 128 PATIENTS (95 MALE, 33 FEMALE, MEDIAN AGE AT THE FIRST ABLATION PROCEDURE WAS 54.5 YEARS, RANGE 19¿75 YEARS). ON AVERAGE, 1.7 ABLATION PROCEDURES PER PATIENT FOR AF OR 2 PROCEDURES PER PATIENT CONSIDERING ALSO AU ABLATIONS WERE DONE. THE FOLLOW-UP WAS SUCCESSFUL IN 117 PATIENTS (85 MALE, 32 FEMALE) ON AVERAGE FOR 11.7 YEARS (MEDIAN 140 MONTHS, RANGE 21¿230). TEN PATIENTS DIED (6 MALE, 4 FEMALE); DEATH WAS NOT RELATED TO ABLATION PROCEDURE. THE MOST FREQUENT COMORBIDITIES WERE MALIGNANT DISEASE AND THYROID DYSFUNCTION. THE PROBABILITY OF STABILE SINUS RHYTHM AFTER 10 YEARS OF FOLLOW-UP WAS 50%, WITH FIRST-YEAR DROP OF 15% AND A LINEAR DROP OF 4% PER YEAR AFTERWARDS. ABLATION PROCEDURE WAS SUCCESSFUL IN 54 PATIENTS (46%), PARTIALLY SUCCESSFUL IN 25 (21%) AND UNSUCCESSFUL IN 38 PATIENTS (33%, WORSE IN FEMALES, P < 0.05). ONLY 46 (16%) ABLATION PROCEDURES WERE PERFORMED OVER THE LAST 10 YEARS. THIRTY-EIGHT PATIENTS (32%) WERE TREATED WITH AADS, MAINLY WITH AMIODARONE AND PROPAFENONE. TAMPONADE WAS THE ONLY SERIOUS COMPLICATION IN 5 PATIENTS (4%); NONE OF THEM NEEDED SURGICAL INTERVENTION. CONCLUSION: CATHETER ABLATION OF AF IS A REASONABLY LONG-TERM SUCCESSFUL, SAFE AND, ACCORDING TO REPORTED DATA, COST-EFFICIENT PROCEDURE, AND THEREFORE RECOMMENDED FOR THE MAJORITY OF PATIENTS WITH AF. IN ADDITION, ELIMINATION OF REVERSIBLE RISK FACTORS, APPROPRIATE AAD TREATMENT AND ANTICOAGULATION ARE OF GREAT IMPORTANCE FOR THOROUGH MANAGEMENT OF PATIENTS WITH AF. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED NAMED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ARC-D OR -F IRRIGATION ABLATION CATHETERS - ARTICLE DOES NOT SPECIFY A SPECIFIC PLATFORM BUT IDENTIFIES AS "BIOSENSE-WEBSTER, DIAMOND-BAR" THAT WAS USED. OTHER NAMED BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LASSO MAPPING CATHETER. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (POSSIBLY ASSOCIATED WITH THE SUSPECTED DEVICE): QTY 5 CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666184 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L LASSO MAPPING CATHETER.