BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSIUS¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 16544568 · Received March 15, 2023

    Report

    Report Number
    2029046-2023-00533
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    May 1, 2002
    Report Date
    March 15, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:SCHWACKE H, BRANDT A, RAMEKEN M, VATER M, FISCHER F, SENGES J, SEIDL K. LANGZEITERGEBNISSE NACH AV-KNOTEN-MODULATION BEI 387 KONSEKUTIVEN PATIENTEN MIT AV-KNOTEN-REENTRY-TACHYKARDIE [LONG-TERM OUTCOME OF AV NODE MODULATION IN 387 CONSECUTIVE PATIENTS WITH AV NODAL REENTRANT TACHYCARDIA]. Z KARDIOL. 2002 MAY;91(5):389-95. GERMAN. DOI: 10.1007/S00392-002-0792-4. PMID: 12132285. 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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:SCHWACKE H, BRANDT A, RAMEKEN M, VATER M, FISCHER F, SENGES J, SEIDL K. LANGZEITERGEBNISSE NACH AV-KNOTEN-MODULATION BEI 387 KONSEKUTIVEN PATIENTEN MIT AV-KNOTEN-REENTRY-TACHYKARDIE [LONG-TERM OUTCOME OF AV NODE MODULATION IN 387 CONSECUTIVE PATIENTS WITH AV NODAL REENTRANT TACHYCARDIA]. Z KARDIOL. 2002 MAY;91(5):389-95. GERMAN. DOI: 10.1007/S00392-002-0792-4. PMID: 12132285. OBJECTIVE/METHODS/STUDY DATA: AIM OF THIS STUDY WAS TO ASSESS THE LONG-TERM RESULTS OF AV-NODE MODULATION IN PATIENTS WITH AV NODAL REETRANT TACHYCARDIA. METHODS: FROM DECEMBER 1991 UNTIL SEPTEMBER 1999, AV NODE MODULATION (ABLATION OF THE FAST PATHWAY OR ABLATION/MODIFICATION OF THE SLOW PATHWAY) WAS PERFORMED IN 387 CONSECUTIVE PATIENTS WITH CLINICALLY APPARENT AV NODAL REENTRANT TACHYCARDIA. FOLLOW-UP DATA WAS AVAILABLE IN 95% OF PATIENTS WITH A MEAN OF 41 +/- 26 MONTHS AFTER ABLATION. RESULTS: ACUTE SUCCESS RATE WAS 97%. DURING LONG-TERM FOLLOW-UP RECURRENCE RATE WAS 7.4% WITHOUT ANY DIFFERENCE BETWEEN FAST AND SLOW PATHWAY ABLATION. RECURRENCE OCCURRED IN 23% OF PATIENTS WITH PERSISTENT DUAL AV NODE PHYSIOLOGY AFTER ABLATION (MODIFICATION OF THE SLOW PATHWAY) IN CONTRAST TO 3% WITHOUT DUAL AV NODE PHYSIOLOGY (ABLATION OF THE SLOW PATHWAY) (P = 0.002). THE PRESENCE OF A DUAL AV NODE PHYSIOLOGY AFTER SLOW PATHWAY MODULATION WAS THE ONLY PREDICTOR OF RECURRENCE DURING LONG-TERM FOLLOW-UP. THE COMPLICATION RATE WAS 5.7%. THE INCIDENCE OF COMPLETE HEART BLOCK WAS 1% WITHOUT ANY DIFFERENCE BETWEEN FAST AND SLOW PATHWAY ABLATION. CONCLUSIONS: CATHETER MODULATION OF THE AV NODE FOR THE TREATMENT OF AV NODAL REENTRANT TACHYCARDIA IS EFFECTIVE AND SAFE. DURING LONG-TERM FOLLOW-UP, THE RECURRENCE RATE WAS LOW. MODULATION OF THE SLOW PATHWAY IS ASSOCIATED WITH A SIGNIFICANTLY HIGHER RECURRENCE RATE THAN ABLATION OF THE SLOW PATHWAY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED NAMED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS:4-MM ABLATION CATHETER (CELSIUS). OTHER NAMED BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: RADIOFREQUENCY GENERATOR (STOCKERT) - TARGET TEMPERATURE OF 60°C AND A MAXIMUM ENERGY OF 30 W INITIALLY AND 50 W IF THE TARGET TEMPERATURE WAS NOT REACHED NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. EXACT QUANTITIES OF THE SUSPECTED BIOSENSE WEBSTER DEVICE CANNOT BE ACCURATELY DETERMINED AS THE ADVERSE EVENTS ARE CAPTURED AND SUMMARIZED BY OCCURRENCES AND NOT INDIVIDUAL CASES. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (POSSIBLY ASSOCIATED WITH THE SUSPECTED DEVICE): QTY 3 THIRD DEGREE AV BLOCK TREATED WITH PACEMAKER IMPLANTATION (ARTICLE REPORTS 4 AND OFFERS CLARIFICATION THAT THE 4TH IS NOT RELATED TO THE ABLATION PROCEDURE). QTY 3 AV FISTULA (NO DISCUSSION REGARDING THE INTERVENTION FOR THIS COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835052 CELSIUS¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention