BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER

    MDR report key: 11862971 · Received May 21, 2021

    Report

    Report Number
    2134265-2021-06645
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ADDITIONAL INFORMATION ADDED TO B5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021 AN VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WAS COMPLETED WITH A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER AND INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER. TWO DAYS FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED A STROKE ON (B)(6) 2021. BLURRING IN THE LEFT EYE WAS OBSERVED AND NO INTERVENTION WAS NOTED. THE CAUSE OF THE STROKE IS UNKNOWN TO THE PHYSICIAN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SUSPECTED CAUSE OF THE STROKE WAS DUE TO 2 NON-BOSTON SCIENTIFIC SHEATHS. AFTER THE FIRST SHEATH FAILED, A SECOND SHEATH WAS PREPPED ON THE TABLE. DURING PREPARATION, IT BEGAN TO CRACK AS THE DILATOR WAS INSERTED. THE SECOND SHEATH WAS EXCHANGED AND THE PROCEDURE RESUMED WITH ANOTHER SHEATH FROM A DIFFERENT MANUFACTURER. THE PROCEDURE WAS SUCCESSFUL WITH THE PATIENT LEAVING THE ROOM WITH NO COMPLICATIONS. THE PATIENT IS ALMOST FULLY RECOVERED AT THE MOST RECENT FOLLOW-UP AND IS EXPECTED TO FULLY RECOVER. THE PHYSICIAN DID NOT ATTRIBUTE THE EVENT TO ANY OF THE BOSTON SCIENTIFIC PRODUCTS.

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 AN VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WAS COMPLETED WITH A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER AND INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER. TWO DAYS FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED A STROKE ON (B)(6) 2021. BLURRING IN THE LEFT EYE WAS OBSERVED AND NO INTERVENTION WAS NOTED. THE CAUSE OF THE STROKE IS UNKNOWN TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759512 INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER| INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER| INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER