BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF BI-DIRECTIONAL CATHETER

    MDR report key: 13122270 · Received December 30, 2021

    Report

    Report Number
    2029046-2021-02279
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    December 6, 2021
    Report Date
    April 1, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835002812
    PMA / PMN Number
    P030031/S025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 14-JAN-2022, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT. IT WAS REPORTED THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT IS IMPROVED. THE PHYSICIAN CONSIDERED THE AE TO BE UNRELATED TO BWI PRODUCT, BUT MADE NO ADDITIONAL COMMENTS. THE EVENT IS BELIEVED TO HAVE HAPPENED DURING THE MAPPING PHASE OF THE PROCEDURE. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THERE WAS NO EVIDENT OF STEAM POP. A SMARTABLATE GENERATOR WAS USED IN THE PROCEDURE. 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

    MANUFACTURER'S REF # (B)(4) ON(B)(6)-2022, IT WAS NOTICED THAT "UNK_PREFACE SHEATH" WAS INCORRECTLY REPORTED AS A CONCOMITANT DEVICE IN FIELD "D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES". THERE IS NO INDICATION THAT A PREFACE SHEATH WAS USED DURING THIS CASE, AS SUCH, PLEASE REMOVE/CONSIDER IT REMOVED FROM FIELD D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES.

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND THE PATIENT HAD THROMBOSIS AND CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. IT WAS REPORTED THAT TAMPONADE OCCURRED IN A PROCEDURE WITH PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) WHICH HAD BEEN CONVENTIONALLY PERFORMED SINCE AROUND 19:00 ON DEC. 6. ALTHOUGH DRAINAGE WAS CONDUCTED, THE CONDITION DID NOT IMPROVE, AND THROMBUS WAS PULLED IN. BECAUSE THE SITE OF BLEEDING WAS UNKNOWN, SURGERY FOR HEART-LUNG MACHINE PLACEMENT BY MIDLINE INCISION WAS PERFORMED. AFTER OPERATION FROM AROUND 11:00 ON DEC. 6 TO AROUND 5:00 ON THE FOLLOWING DAY, THE PATIENT IS CURRENTLY BEING FOLLOWED UP IN INTENSIVE CARE UNIT (ICU). THORACOTOMY WAS PERFORMED. BLOOD WAS OBSERVED IN THE LEFT VENTRICULAR POSTERIOR WALL, AND TREATMENT WITH HEMOSTAT WAS PERFORMED. BLEEDING WAS NOT FROM A SINGLE POINT, BUT A FINDING THAT SLOWLY BLEEDS FROM THE ENTIRE AREA. ADDITIONAL INFORMATION RECEIVED INDICATED EXTUBATION WAS SCHEDULED TO BE PERFORMED (B)(6) 2021. ALTHOUGH RENAL FUNCTION DECREASED WAS NOTED, IT WAS CONFIRMED BY CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) THAT HEMORRHAGE HAD CEASED. THE PATIENT AWAKENS, CONTINUE TO MONITOR THE PROGRESS AFTER BLOOD PRESSURE RECOVERY. THE BACKGROUND THAT LED TO TAMPONADE WAS AS FOLLOWS; ALTHOUGH THE CELSIUS C CURVE IS ISSUED, THE CATHETER DID NOT REACH THE ABLATION AREA, AND THERMOCOOL® SF BI-DIRECTIONAL CATHETER WITH A DIFFERENT DIAMETER OF CURVE WAS RELEASED, AND WHEN IT WAS APPROACHED THE LEFT VENTRICLE (LV) RETROGRADELY, THERE WAS A FEELING OF STRONG CONTACT WITH THE LATERAL SIDE. AFTER THE PROCEDURE, WHEN WE REVIEWED THE FLUOROSCOPIC IMAGE, HEARD THAT THERE WAS A FINDING THAT THE CARDIAC CONTRACTION HAD WORSENED AFTER MAKING CONTACT. THE ATTENDING PHYSICIAN AS WELL AS THE DR WHO WAS PRESENT AT THE OPERATING ROOM CONFIRMED THAT THERE WAS NO CAUSAL RELATIONSHIP WITH THE PRODUCT. CONTRAST-ENHANCED CT CONFIRMED CESSATION OF HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020544 THERMOCOOL® SF BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC BDI35DFRT 30274860L 10846835002812

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H BUNDLE-CELSIUS 4MM-D7TCCL252RT-000063| UNK_PREFACE SHEATH| UNK_SMARTABLATE GENERATOR