VERSACROSS ACCESS SOLUTION

Description of Event or Problem

IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. NO EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO GET LEFT ATRIAL ACCESS, HOWEVER THE RF WIRE WAS NOT VISUALIZED IN LEFT ATRIUM AFTER CROSSING. THE PATIENT BLOOD PRESSURE THEN DROPPED AND PERICARDIAL TAMPONADE / FLUID WAS SEEN BUILDING AROUND THE LEFT VENTRICULAR (LV). PATIENT WAS GIVEN MEDICATION AND WAS PREPPED FOR PERICARDIAL TAP. AROUND 600 ML OF DARK RED COLOR FLUID WAS REMOVED. THE PE OCCURRED DURING TRANSSEPTAL CROSSING. THE CASE WAS ABORTED. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME. THE PATIENT WAS ADMITTED OVER THE WEEKEND AND EXPECTED TO FULLY RECOVER. A NON-BOSTON SCIENTISTIC GUIDEWIRE WAS USED AND SEVERAL EXCHANGES WERE MADE INTO THE SUPERIOR VENA CAVA. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER REPORTED THAT THE WIRE TENTING LOOKED APPROPRIATE (1-3MM). THE IMAGING WITH TEE WAS EXTREMELY DIFFICULT WITH A CARDIOLOGIST GETTING THE IMAGES. THE SEPTAL WINDOW WAS EXTREMELY TO IMAGED. TO SEE A/P AND ALSO SUPERIOR/ INFERIOR AT THE SAME TIME WAS VERY DIFFICULT. TAMPONADE WAS CONFIRMED. ARTERIAL BLOOD PRESSURE WAS DROPPED. FLUID COLLECTED AROUND THE VENTRICLES WAS ALSO REPORTED. NO DEVICE MALFUNCTION WAS NOTED. THE PHYSICIAN DID NOT BELIEVE THE DEVICE WAS AT FAULT. THE ACT WAS THERAPEUTIC. THE TIME OF DISCHARGE WAS NOT DISCLOSED. THE DEVICE WAS DISPOSED.

Additional Manufacturer Narrative

DUE TO ADDITIONAL INFORMATION RECEIVED, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR THE UPDATED FIELDS PATIENT IDENTIFIER (A1) AND DATE OF BIRTH (A2), IN SECTION A - PATIENT INFORMATION, DESCRIBE EVENT OR PROBLEM (B5), IN SECTION B - ADVERSE EVENT/PRODUCT PROBLEM, MANUFACTURER NAME, MANUFACTURER ADDRESS 1, MANUFACTURER CITY, MANUFACTURER STATE, MANUFACTURER ZIP/POSTAL CODE, MFR COUNTRY (D3), MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE, AND UNIQUE IDENTIFIER (UDI) # (D4), IN SECTION D - SUSPECT MEDICAL DEVICE, AND PATIENT CODES (F1 AND H6), IN SECTION F - FOR USE BY UF/IMPORTER AND H - DEVICE MANUFACTURERS ONLY. 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

DUE TO ADDITIONAL INFORMATION RECEIVED, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR THE UPDATED FIELDS OUTCOMES ATTRIB TO ADV EVENT (B2), DESCRIBE EVENT OR PROBLEM (B5), IN SECTION B - ADVERSE EVENT/PRODUCT PROBLEM AND IMPACT CODES (F10 AND H6), IN SECTION F - FOR USE BY UF/IMPORTER AND H - DEVICE MANUFACTURERS ONLY. 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

IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. NO EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO GET LEFT ATRIAL ACCESS, HOWEVER THE RF WIRE WAS NOT VISUALIZED IN LEFT ATRIUM AFTER CROSSING. THE PATIENT BLOOD PRESSURE THEN DROPPED AND PERICARDIAL TAMPONADE / FLUID WAS SEEN BUILDING AROUND THE LEFT VENTRICULAR (LV). PATIENT WAS GIVEN MEDICATION AND WAS PREPPED FOR PERICARDIAL TAP. AROUND 600 ML OF DARK RED COLOR FLUID WAS REMOVED. THE PE OCCURRED DURING TRANSSEPTAL CROSSING. THE CASE WAS ABORTED. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME. THE PATIENT WAS ADMITTED OVER THE WEEKEND AND EXPECTED TO FULLY RECOVER. A NON-BOSTON SCIENTISTIC GUIDEWIRE WAS USED AND SEVERAL EXCHANGES WERE MADE INTO THE SUPERIOR VENA CAVA. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER REPORTED THAT THE WIRE TENTING LOOKED APPROPRIATE (1-3MM). THE IMAGING WITH TEE WAS EXTREMELY DIFFICULT WITH A CARDIOLOGIST GETTING THE IMAGES. THE SEPTAL WINDOW WAS EXTREMELY TO IMAGED. TO SEE A/P AND ALSO SUPERIOR/ INFERIOR AT THE SAME TIME WAS VERY DIFFICULT. TAMPONADE WAS CONFIRMED. ARTERIAL BLOOD PRESSURE WAS DROPPED. FLUID COLLECTED AROUND THE VENTRICLES WAS ALSO REPORTED. NO DEVICE MALFUNCTION WAS NOTED. THE PHYSICIAN DID NOT BELIEVE THE DEVICE WAS AT FAULT. THE ACT WAS THERAPEUTIC. THE TIME OF DISCHARGE WAS NOT DISCLOSED. THE DEVICE WAS DISPOSED. IT WAS FURTHER REPORTED THAT THE DATE OF THE PATIENTS PASSING WAS 23DEC2025. FAMILY CHOSE TO WITHDRAW CARE AFTER PATIENT COULDN'T RECOVER FROM PNEUMONIA. THE DEATH WAS NOT DUE TO THE PROCEDURE.

Additional Manufacturer Narrative

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. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. GOOD FAITH EFFORTS TO OBTAIN THE INFORMATION ARE IN PROGRESS. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED IF THE INFORMATION IS RECEIVED. GOOD FAITH EFFORT ATTEMPTS TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT ARE IN PROGRESS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. NO EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO GET LEFT ATRIAL ACCESS, HOWEVER THE RF WIRE WAS NOT VISUALIZED IN LEFT ATRIUM AFTER CROSSING. THE PATIENT BLOOD PRESSURE THEN DROPPED AND PERICARDIAL TAMPONADE / FLUID WAS SEEN BUILDING AROUND THE LEFT VENTRICULAR (LV). PATIENT WAS GIVEN MEDICATION AND WAS PREPPED FOR PERICARDIAL TAP. AROUND 600 ML OF DARK RED COLOR FLUID WAS REMOVED. THE PE OCCURRED DURING TRANSSEPTAL CROSSING. THE CASE WAS ABORTED. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME. THE PATIENT WAS ADMITTED OVER THE WEEKEND AND EXPECTED TO FULLY RECOVER. A NON-BOSTON SCIENTITIC GUIDEWIRE WAS USED AND SEVERAL EXCHANGES WERE MADE INTO THE SUPERIOR VENA CAVA. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.