BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17347570 · Received July 18, 2023

    Report

    Report Number
    2029046-2023-01531
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 18, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE THAT INCLUDED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT DURING A VT ABLATION PROCEDURE, THERE WAS AN ADVERSE EVENT. THE CALLER REPORTED THAT THEY WERE SEVERAL HOURS INTO THE PROCEDURE AND HAD DONE MAPPING AND ABLATION IN THE LEFT VENTRICLE AND NOTICED A SUSPECTED PERFORATION IN THE CORONARY SINUS OF THE HEART. THEY WERE PERFORMING A ROUTINE SWEEP WITH THE SOUNDSTAR CATHETER AND OBSERVED ACCUMULATED FLUID OUTSIDE THE LEFT VENTRICLE. THE PERICARDIAL EFFUSION WAS DISCOVERED AND CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THERE WAS NO CHANGE IN THE PATIENT'S VITALS AT THAT TIME. THEY DECIDED TO PERFORM A PERICARDIOCENTESIS AND REMOVED APPROXIMATELY 200 CCS OF FLUID. A DRAIN WAS PLACED INTO THE PATIENT. THE PATIENT'S BLOOD PRESSURE DROPPED APPROXIMATELY AN HOUR LATER. THE CALLER REPORTED THAT THEY HAD TO REMOVE 200 MORE CCS OF FLUID AT THAT TIME. THE CALLER REPORTED THAT THEY HAD A "BAYLISS / BOSTON SCIENTIFIC MAP IT CATHETER" IN THE DISTAL CORONARY SINUS AND THE PHYSICIAN BELIEVED THIS TO BE THE SUSPECTED CAUSE. THE CALLER REPORTED THAT THE PHYSICIAN ASSOCIATED THE PERFORATION WITH A CARDIOVERSION THAT WAS PERFORMED. (THE CALLER REPORTED THAT IT WAS 150 TO 200 JOULES.) THE CALLER REPORTED THAT ALMOST 24 HOURS LATER THE DRAIN REMAINED IN PLACE AND THE PATIENT WAS STABLE. THE OUTCOME OF ADVERSE EVENT WAS REPORTED AS RESOLVING AT LAST KNOWN UPDATE. THE DEVICES USED WERE: OPTRELL CATHETER, A SOUNDSTAR 8 FRENCH CATHETER, AND A SMARTTOUCH SF CATHETER. THE CALLER COULD PROVIDE NO LOT NUMBER FOR THE SMARTTOUCH SF CATHETER. THE CALLER COULD PROVIDE NO OTHER CATHETER OR BIOSENSE WEBSTER PRODUCT INFORMATION. THE ABLATION CATHETER IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139764 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| R| H UNK BAYLISS/ BOSTON SCIENTIFIC MAPPING CATHETER| UNK_OPTRELL MAPPING CATHETER| UNK_SOUNDSTAR