BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARX FIT

    MDR report key: 21267199 · Received January 29, 2025

    Report

    Report Number
    2124215-2025-04481
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAE
    UDI-DI
    08714729992622
    PMA / PMN Number
    P220032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM - UPDATED TO PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT CONDITION AND INTERVENTION PROVIDED VIA AI RECORD. H6: PATIENT CODING - CORRECTION TO EXCLUDE PERICARDIAL EFFUSION, CARDIAC TAMPONADE CAPTURES THIS. H6: IMPACT CODING - ADDITION OF MEDICATION REQUIRED TO CAPTURE IV MEDS GIVEN AS FURTHER REPORTED VIA AI. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    CLINICAL STUDY (B)(6) FOR POLARX PAS; SUBJECT ID # (B)(6). IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT EXPERIENCED NAUSEA, HYPOTENSION AND WAS SUBSEQUENTLY DIAGNOSED WITH CARDIAC TAMPONADE AND PERICARDIAL EFFUSION, WHICH REQUIRED SURGICAL INTERVENTION. DURING A PULMONARY VEIN ISOLATION CRYOABLATION PROCEDURE, A POLARX FIT CATHETER WAS SELECTED FOR USE. POST TREATMENT, THE PATIENT EXPERIENCED EPISODES OF NAUSEA AND HYPOTENSION. AN URGENT ECHOCARDIOGRAM AND ULTRASOUND WERE PERFORMED AND SHOWED A MODERATE-SIZED PERICARDIAL EFFUSION, 1.8CM AT MAX. THIS EFFUSION CAUSED CARDIAC TAMPONADE. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE A PERICARDIOCENTESIS WAS PERFORMED AND 275CC OF SANGUINOUS DRAINAGE WAS REMOVED. THIS EVENT RESULTED IN IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2025, IMAGING PERFORMED (ULTRASOUND) SHOWED THAT THE ISSUE HAD RESOLVED. THE DEVICE WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

    Description of Event or Problem · 0

    CLINICAL STUDY (B)(6) FOR POLARX PAS; SUBJECT ID #(B)(6). IT WAS REPORTED THAT POST PROCEDURE THE PATIENT EXPERIENCED NAUSEA, HYPOTENSION AND WAS SUBSEQUENTLY DIAGNOSED WITH CARDIAC TAMPONADE AND PERICARDIAL EFFUSION, REQUIRING SURGICAL INTERVENTION. DURING A PULMONARY VEIN ISOLATION CRYOABLATION PROCEDURE, A POLARX FIT CATHETER WAS SELECTED FOR USE. POST TREATMENT, THE PATIENT EXPERIENCED EPISODES OF NAUSEA AND HYPOTENSION. AN URGENT ECHOCARDIOGRAM AND ULTRASOUND WAS PERFORMED AND SHOWED A MODERATE-SIZED PERICARDIAL EFFUSION, 1.8CM AT MAX. THIS EFFUSION CAUSED CARDIAC TAMPONADE. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE A PERICARDIOCENTESIS WAS PERFORMED AND 275CC OF SANGUINEOUS DRAINAGE WAS REMOVED. THIS EVENT RESULTED IN IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION. THE PATIENT WAS DISCHARGED ON (B)(6)2025, IMAGING PERFORMED (ULTRASOUND) SHOWED THAT THE ISSUE HAD RESOLVED. THE DEVICE WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS. IT WAS FURTHER CLARIFIED THAT ON (B)(6)2024, POST DRAINAGE OF THE EFFUSION, THE PATIENT CONTINUED TO EXPERIENCE HYPOTENSION (BLOOD PRESSURE FELL INTO THE 80'S). THE PATIENT WAS STARTED ON A NOREPINEPHRINE IV DRIP FOR APPROXIMATELY 6 HOURS. THE NOREPINEPHRINE DRIP WAS STOPPED, AND A DOPAMINE DRIP WAS STARTED. AGAIN, THEY CONFIRMED THAT ULTRASOUND SHOWED THAT THE ISSUE HAD RESOLVED ON (B)(6)2025 AND THE PATIENT WAS DISCHARGED ON (B)(6)2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607761 POLARX FIT CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BOSTON SCIENTIFIC CORPORATION M004CRBS2060 0032785070 08714729992622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| O