BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 15272759 · Received August 23, 2022

    Report

    Report Number
    2029046-2022-01951
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    June 27, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCIACCA V, FINK T, EITEL C, HEEGER CH, SANO M, REIL JC, EITEL I, KUCK KH, VOGLER J, TILZ RR. REPEAT CATHETER ABLATION IN PATIENTS WITH ATRIAL ARRHYTHMIA RECURRENCE DESPITE DURABLE PULMONARY VEIN ISOLATION. J CARDIOVASC ELECTROPHYSIOL. 2022 JUN 27. DOI: 10.1111/JCE.15610. EPUB AHEAD OF PRINT. PMID: 35761754. 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: SCIACCA V, FINK T, EITEL C, HEEGER CH, SANO M, REIL JC, EITEL I, KUCK KH, VOGLER J, TILZ RR. REPEAT CATHETER ABLATION IN PATIENTS WITH ATRIAL ARRHYTHMIA RECURRENCE DESPITE DURABLE PULMONARY VEIN ISOLATION. J CARDIOVASC ELECTROPHYSIOL. 2022 JUN 27. DOI: 10.1111/JCE.15610. EPUB AHEAD OF PRINT. PMID: 35761754. OBJECTIVE/METHODS/STUDY DATA: THE ARTICLE PRESENTED A STUDY TO ANALYZE EFFICACY OF EXTENDED ABLATION MANEUVERS IN PATIENTS WITH ARRHYTHMIA RECURRENCES DESPITE DURABLE PULMONARY VEIN ISOLATION (PVI). THE PATIENT POPULATION COMES FROM CONSECUTIVE PATIENTS WITH DOCUMENTATION OF DURABLE PVI DURING A REPEAT PROCEDURE BETWEEN JUN 2015 AND JUN 2019 AT THE LISTED FACILITY IN GERMANY. PATIENTS UNDERWENT SUBSTRATE MODIFICATION WITH CREATION OF LINEAR LESIONS AND/OR MECHANISM-SPECIFIC ATRIAL TACHYCARDIA (AT) ABLATION. THERE WERE 74 PATIENTS WITH 1 OR MORE REPEAT ABLATION PROCEDURES AND DURABLE PVI DURING REPEAT PROCEDURES WERE ANALYZED. OUT OF THE 74, 31 WERE FEMALE WITH THE AGE OF 66.1 +/- 10.7 YEARS AT THE INITIAL PROCEDURE AND AGE OF 68.9 +/- 10.6 YEARS AT THE TIME OF THE INDEX PROCEDURE (REPEAT PROCEDURE IN WHICH DURABLE PVI WAS DOCUMENTED FOR THE 1ST TIME). DOUBLE TRANSSEPTAL PUNCTURE WAS PERFORMED USING FLUOROSCOPIC GUIDANCE AND 8.5 F TRANSSEPTAL SHEATHS. ALL INDEX PROCEDURES EXCEPT 1 WERE PERFORMED AS RADIOFREQUENCY (RF) CATHETER ABLATION UNDER GUIDANCE OF AN ELECTROANATOMICAL 3-D MAPPING SYSTEM (CARTO 3). ABLATION STRATEGY AT INDEX PROCEDURE WAS DEPENDENT ON THE MODE OF ARRHYTHMIA RECURRENCE. A LASSO CATHETER WAS ALSO USED INSIDE THE LEFT ATRIAL APPENDAGE (LAA) TO DOCUMENT DISAPPEARANCE OF LAA POTENTIALS. IN PATIENTS WITH AT AS MODE OF RECURRENCE WITHOUT AF DOCUMENTATION, ABLATION WAS GUIDED BY THE VISITAG MODULE. CONTACT-FORCE SENSING CATHETERS (THERMOCOOL STSF) WERE USED IN ALL PROCEDURES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 (WITH VISITAG MODULE), LASSO CATHETER NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 8.5 F TRANSSEPTAL SHEATHS (SL 1: ST JUDE MEDICAL). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 2 PERICARDIAL TAMPONADE - NO INTERVENTION NOR PATIENT OUTCOME WERE LISTED IN THE ARTICLE FOR THIS AE. QTY 1 PERIPROCEDURAL STROKE - NO INTERVENTION NOR PATIENT OUTCOME WERE LISTED IN THE ARTICLE FOR THIS AE. QTY 1 TIA - NO INTERVENTION WAS LISTED IN THE ARTICLE FOR THIS AE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494154 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening 8.5 F TRANSSEPTAL SHEATHS (SL 1: ST JUDE MEDICAL)| CARTO 3 (WITH VISITAG MODULE)| LASSO CATHETER