BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 14485330 · Received May 24, 2022

    Report

    Report Number
    2029046-2022-01116
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 28, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012217
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. HOWEVER, INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE PATIENT SUFFERED CARDIAC PERFORATION. AFTER THE TRANSSEPTAL PUNCTURE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS NOTED TO BE IN THE PERICARDIUM AND A BLOOD EFFUSION (PERICARDIAL EFFUSION) WAS NOTICED. THE PROCEDURE WAS INTERRUPTED, AND THE CATHETER PULLED OUT OF THE PATIENT'S HEART. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT TO BE PROCEDURE RELATED. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. DEVICE INVESTIGATION DETAILS: THE DEVICE INVESTIGATION HAS BEEN COMPLETED WHICH INCLUDED PERFORMING A MANUFACTURING RECORD EVALUATION (MRE). THE MANUFACTURING RECORD EVALUATION PERFORMED FOR THE FINISHED DEVICE WITH LOT NUMBER 30704149L IDENTIFIED NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION. STILL NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. BASED ON THE COMPLETED MRE, THE H4. DEVICE MANUFACTURE DATE HAS BEEN POPULATED WITH 22-DEC-2021. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE PATIENT SUFFERED CARDIAC PERFORATION. AFTER THE TRANSSEPTAL PUNCTURE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS NOTED TO BE IN THE PERICARDIUM AND A BLOOD EFFUSION (PERICARDIAL EFFUSION) WAS NOTICED. THE PROCEDURE WAS INTERRUPTED, AND THE CATHETER PULLED OUT OF THE PATIENT'S HEART. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT TO BE PROCEDURE RELATED. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. A TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED WITH A HEART SPAN FROM BIOSENSE WEBSTER. ABLATION WASN¿T PERFORMED, AS SUCH, THE SMARTABLATE GENERATOR WAS NOT USED. IT WAS NOTICED THAT THEY WERE IN THE PERICARDIUM DURING THE MAPPING PHASE. THIS WILL BE CODED AS CARDIAC PERFORATION BECAUSE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS NOTED TO BE IN THE PERICARDIUM. THERE IS NO MENTION OF PERICARDIOCENTESIS OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473790 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128207 30704149L 10846835012217

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L 71CM TRANSSEPTAL NEEDLE| HEARTSPAN TRANSSEPTAL NEEDLE