BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECANAV ELECTROPHYSIOLOGY CATHETER

    MDR report key: 10172358 · Received June 19, 2020

    Report

    Report Number
    2029046-2020-00729
    Event Type
    Injury
    Date Received
    June 19, 2020
    Date of Event
    May 26, 2020
    Report Date
    May 26, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835008807
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 22, 2020. THE PATIENT WAS AT A NORMAL WEIGHT. THIS ADVERSE EVENT DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. NO ABLATION WAS PERFORMED PRIOR TO THE DISCOVERY OF THE EFFUSION. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE FLOW SETTING WAS 4ML/MIN AS FOR MAPPING. THE PHYSICIAN INFORMATION WAS PROVIDED. THEREFORE, PROCESSED ¿E1. INITIAL REPORTER TITLE¿, ¿E1. INITIAL REPORTER FIRST NAME¿, ¿E1. INITIAL REPORTER LAST NAME¿, ¿E1. INITIAL REPORTER EMAIL¿, ¿E2. HEALTH PROFESSIONAL?¿, AND ¿E3. INITIAL REPORTER OCCUPATION¿. DEVICE EVALUATION SUMMARY WAS COMPLETED ON JULY 8, 2020. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITION. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, AN ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE DEFLECTION TEST WAS PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT ((B)(6) YEAR OLD) UNDERWENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH DECANAV ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING THE MAPPING PHASE, THE CORONARY SINUS CATHETER (DECANAV ELECTROPHYSIOLOGY CATHETER) WAS PLACED AND TRANSSEPTAL WAS PERFORMED USING BRK NEEDLE UNDER FLUOROSCOPY AND CONTRAST GUIDANCE. THE MAPPING OF THE LEFT ATRIUM (LA) WAS STARTED, BUT BECAUSE OF A DIFFICULT ANATOMY, THE PHYSICIAN WENT EXITED THE STUDY TO PERFORM SEGMENTATION USING COMPUTER TOMOGRAPHY (CT). DURING THE SEGMENTATION, THE PHYSICIAN NOTICED A DROP IN THE PATIENT¿S BLOOD PRESSURE. AN ECHO WAS PERFORMED AND REVEALED A PERICARDIAL EFFUSION. THE EFFUSION WAS ASPIRATED WITH A PERICARDIAL PUNCTURE AND THE TAMPONADE COULD BE RESOLVED. UNKNOWN AMOUNT OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE OUTCOME FOR THE PATIENT IS UNKNOWN. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION AND IF ANY ADDITIONAL INTERVENTION WAS PERFORMED. IN THE PHYSICIAN¿S OPINION, THE PERFORATION OCCURRED DURING THE TRANSSEPTAL. DESPITE THE PHYSICIAN¿S OPINION, THE EVENT WILL BE CONSERVATIVELY REPORTED UNDER THE DECANAV ELECTROPHYSIOLOGY CATHETER. THERE IS NO INDICATION THAT THE QDOT WAS INSERTED. 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
    638103 DECANAV ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC R7F282CT 30357352M 10846835008807

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R PENTARAY NAV ECO 7FR, F, 2-6-2.| QDOT MICRO, BI, TC, D-F.| UNKNOWN BRAND BRK NEEDLE.