BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

    MDR report key: 4572664 · Received March 5, 2015

    Report

    Report Number
    2029046-2015-00049
    Event Type
    Injury
    Date Received
    March 5, 2015
    Date of Event
    May 31, 2010
    Report Date
    February 9, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: OTHER BWI PRODUCTS WERE USED DURING THIS PROCEDURE: LASSO MAPPING CATHETER WAS USED DURING THIS CLINICAL TRIAL. OTHER DEVISES: 7-POLAR CATHETER (INQUIRY, ST. JUDE MEDICAL, (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE SOURCE. IT WAS REPORTED THAT PERICARDIAL TAMPONADE OCCURRED IN TWO PATIENTS AND WAS MANAGED SUCCESSFULLY BY PERICARDIOCENTESIS. BASED ON THE NARRATIVE, THERE WERE NO COMPLAINTS REPORTED RELATED TO CATHETER MALFUNCTION IMMEDIATELY AFTER THE PROCEDURE WHICH MIGHT SUGGEST THAT THE COMPLICATION WAS PROCEDURE RELATED AND NOT A MALFUNCTION OF BWI PRODUCT. TITLE: ¿ATRIAL DEFIBRILLATION THRESHOLD AS A NOVEL PREDICTOR OF CLINICAL OUTCOME OF CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION.¿ OBJECTIVE: THE AIM OF THIS STUDY WAS TO EVALUATE THE IMPACT OF ATRIAL DFT AFTER CATHETER ABLATION FOR PERSISTENT AF ON CLINICAL OUTCOME. FROM THE ARTICLE OTHER EVENTS WERE OBSERVED. THESE EVENTS WILL BE REPORTED SEPARATELY. TOTAL OF TWO PATIENTS IN EACH GROUP DEVELOPED PERICARDITIS THAT DID NOT REQUIRE INTERVENTION. SINCE THESE PATIENTS DIDN¿T REQUIRE ANY SURGICAL OR MEDICAL INTERVENTION NOR PROLONG HOSPITALIZATION; THESE EVENTS CONSIDERED TO BE NON-SERIOUS AND NOT REPORTABLE. ONE PATIENT EXPERIENCED TRANSIENT CEREBROVASCULAR ISCHAEMIA, WHICH WAS RESOLVED WITHIN HOURS AFTER THE PROCEDURE. ITS UNKNOWN WHETHER THE PATIENT REQUIRED ANY MEDICAL/SURGICAL INTERVENTION OR PROLONG HOSPITALIZATION. THERE ARE NO DEATH EVENTS AND DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE 4 MM TIP NONIRRIGATED CATHETER MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153599 SIMILAR DEVICE NS7TCBL174HS, PMA # P990025 DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-00 UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R