BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE? NAV

    MDR report key: 24834512 · Received April 9, 2026

    Report

    Report Number
    2124215-2026-19393
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT COMPLICATION OCCURRED. THE PATIENT UNDERWENT A PULSE FIELD ABLATION PROCEDURE. DEVICES USED DURING THE PROCEDURE INCLUDED A FARAWAVE NAV ABLATION CATHETER, FARADRIVE STEERABLE SHEATH, FARAPOINT CATHETER, OPTIMAP CATHETER, AND FARASTAR PFA GENERATOR. DURING TRANSSEPTAL ACCESS, THE FARADRIVE SHEATH WAS INITIALLY ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE; ALTHOUGH THE GUIDEWIRE CROSSED THE SEPTUM, DIFFICULTY WAS REPORTED ADVANCING THE FARADRIVE SHEATH. THE GUIDEWIRE WAS REMOVED AND REPLACED WITH A PROTRACK PIGTAIL WIRE, AFTER WHICH THE FARADRIVE SHEATH ADVANCED SUCCESSFULLY ACROSS THE SEPTUM. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL DIFFICULTY. NO INTRA-PROCEDURAL HYPOTENSION, PATIENT DISTRESS, OR ADVERSE EVENTS WERE REPORTED. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED HYPOTENSION WITH ACUTE ONSET SHORTNESS OF BREATH, RIGHT SIDED CHEST PAIN, BACK PAIN, AND IPSILATERAL PUPIL DILATION. A STROKE ALERT WAS INITIATED, AND THE PATIENT WAS ADMITTED FOR INPATIENT CARE, HOWEVER IT WAS FURTHER CONFIRMED THAT THIS WAS REPORTED IN ERROR AS NO CEREBROVASCULAR ACCIDENT (CVA) OCCURRED. DIAGNOSTIC EVALUATION, INCLUDING CHEST X-RAY, CT IMAGING, LABORATORY TESTING, AND TRANSTHORACIC ECHOCARDIOGRAPHY, IDENTIFIED A LARGE RIGHT SIDED HEMOTHORAX AND FINDINGS CONSISTENT WITH A CVA. THE PATIENT UNDERWENT INVASIVE INTERVENTIONS, INCLUDING CHEST TUBE PLACEMENT, BLOOD PRODUCT TRANSFUSIONS (PRBCS AND FFP), AND RIGHT VIDEO-ASSISTED THORACOSCOPIC SURGERY WITH BRONCHOSCOPY AND DECORTICATION. ANTICOAGULATION THERAPY (PRADAXA) WAS HELD PENDING SURGICAL CLEARANCE AND WAS LATER RESUMED. THE PATIENT REMAINED HOSPITALIZED FOR CONTINUED MONITORING AND SUPPORTIVE CARE AND WAS DISCHARGED ON (B)(6) 2026. AT THE TIME OF REPORTING, THE HEMOTHORAX WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284227 FARAWAVE? NAV NO MATCH QZI BOSTON SCIENTIFIC CORPORATION 0037953756 00191506043193

    Patients

    Seq Age Sex Outcome Treatment
    1