BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECANAV ELECTROPHYSIOLOGY CATHETER

    MDR report key: 12276040 · Received August 4, 2021

    Report

    Report Number
    2029046-2021-01271
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    July 9, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835008807
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A FEMALE PATIENT (55KG) UNDERWENT A SUPRA VENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS. DURING A DIAGNOSTIC ELECTROPHYSIOLOGY (EP) STUDY FOR SVT, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THIS WAS OBSERVED DUE TO A DROP IN BLOOD PRESSURE AND THE HEART BORDER NOT MOVING ON THE X-RAY. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 200 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) FOR OBSERVATION. DEVICE EVALUATION DETAILS: THE DEVICE EVALUATION WAS COMPLETED ON 9-AUG-2021. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE DECANAV ELECTROPHYSIOLOGY CATHETER. PER THE EVENT, SEVERAL TESTS WERE PERFORMED. NO ISSUES WERE OBSERVED ON THE CARTO 3 AND ELECTRICAL TEST. IN ADDITION, THE PRODUCT WAS DEFLECTING AND WAS WORKING CORRECTLY. NO MALFUNCTIONS WERE OBSERVED DURING THE PRODUCT ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30549294M NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF BIOSENSE WEBSTER INC. (BWI) QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 (55KG) UNDERWENT A SUPRA VENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS. DURING A DIAGNOSTIC ELECTROPHYSIOLOGY (EP) STUDY FOR SVT, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THIS WAS OBSERVED DUE TO A DROP IN BLOOD PRESSURE AND THE HEART BORDER NOT MOVING ON THE X-RAY. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 200 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) FOR OBSERVATION. PRIOR TO NOTING THE CT, ABLATION WAS NOT PERFORMED. THE RESPONSE RECEIVED REGARDING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS DUE TO ¿FRAIL OLDER LADY¿. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. IT WAS REPORTED THAT THE PATIENT WAS MONITORED IN THE ICU DUE TO HAVING A CATHETER IN HER PERICARDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173256 DECANAV ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC R7F282CT 30549294M 10846835008807

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R