BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

    MDR report key: 4516748 · Received February 13, 2015

    Report

    Report Number
    2029046-2015-00040
    Event Type
    Injury
    Date Received
    February 13, 2015
    Date of Event
    August 14, 2014
    Report Date
    January 22, 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

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY REPORT (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED. CONCOMITANT PRODUCTS: UNK. (B)(4). SINCE THE LOT NUMBER AND MODEL NUMBER ARE UNKNOWN, NO UDI CAN BE PROVIDED THE PRODUCT WILL NOT BE RETURNED. NO LAB ANALYSIS CAN BE COMPLETED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE, THE ARTICLE IS TITLED ¿INFLUENCE OF THE CONCOMITANT USE OF HEPARIN ON THE EFFECTS OF WARFARIN DURING CATHETER ABLATION FOR ATRIAL FIBRILLATION¿. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE INFLUENCE OF HEPARIN AND PROTAMINE ADMINISTRATION ON THE EFFECTS OF WARFARIN AND ITS SAFETY. IT WAS REPORTED THAT CARDIAC TAMPONADE OCCURRED IN 3 PATIENTS DURING ABLATION PROCEDURES, WHICH WAS RELIEVED WITH PERCUTANEOUS DRAINAGE IN EACH CASE. AN IRRIGATED 3.5-MM-TIP QUADRIPOLAR ABLATION CATHETER (COOL PATH¿ DUO¿, ST JUDE MEDICAL OR THERMO COOL NAVISTAR, BIOSENSE WEBSTER) WAS USED TO DELIVER THE RADIOFREQUENCY ENERGY. IT IS UNCLEAR WHAT ABLATION CATHETER WAS USED DURING THE PROCEDURES THAT CAUSED THE ADVERSE EVENTS. THERE WERE NO REPORTED MALFUNCTION WITH ANY OF BWI CATHETERS AND SYSTEMS USED DURING THIS TRIAL. A STEERABLE 10-POLAR MAPPING CATHETER (INQUIRY¿ LUMA-CATH¿, ST JUDE MEDICAL, (B)(4)) WAS POSITIONED WITHIN THE CORONARY SINUS AND TWO 20-POLAR CIRCUMFERENTIAL MAPPING CATHETERS (LASSO, BIOSENSE WEBSTER, (B)(4) OR INQUIRY¿ OPTIMA¿, ST. JUDE MEDICAL) WERE USED FOR MAPPING. OTHER NON-MDR REPORTABLE INJURIES INCLUDE: 17 PATIENTS HAD MINOR BLEEDING COMPLICATIONS. THESE PATIENTS DID NOT REQUIRE SURGICAL OR MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THEREFORE THESE EVENTS ARE CONSIDERED TO BE NON ¿SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108287 SIMILAR DEVICE NS7TCBL174HS, PMA # P990025 DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-00 UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R