BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24878215 · Received April 14, 2026

    Report

    Report Number
    2029046-2026-01209
    Event Type
    Death
    Date Received
    April 14, 2026
    Date of Event
    April 29, 2025
    Report Date
    May 15, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMARTTOUCH SF APPROVED UNDER P030031/S078. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 19-APR-2026 WHICH INDICATED THAT THE HIGH IMPEDANCE WAS DUE TO CATHETER POSITIONING AND NOT DUE TO MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED ACUTE LEFT CORONARY INJURY DURING SURGERY, CARDIAC ARREST, AND DEATH. THE PATIENT UNDERWENT CARDIAC RADIOFREQUENCY ABLATION, WITH NO FAULT REPORTED DURING THE PROCEDURE, AND THE PATIENT DIED WITHOUT RESCUE AFTER A SUDDEN RESPIRATORY ARREST. THE AUTOPSY REPORT DOCUMENTED THE CAUSE OF DEATH AS ACUTE LEFT CORONARY INJURY DURING SURGERY, CARDIAC ARREST, AND DEATH. ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN'S OPINION ON THE CAUSE OF DEATH IS LEFT MAIN TRUNK INJURY. IT WAS ALSO REPORTED THAT ON (B)(6) 2025, AT 16:00 HOURS, THE PATIENT HAD PREMATURE VENTRICULAR CONTRACTIONS AND UNDERWENT RADIOFREQUENCY ABLATION SURGERY IN THE CATHETERIZATION ROOM. PRIOR TO THE SURGERY, THE TARGET WAS EVALUATED TO BE LOCATED AT THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) SITE THROUGH ELECTROCARDIOGRAM. THEREFORE, A FEMORAL VEIN PUNCTURE WAS PERFORMED TO DELIVER THE CATHETER TO THE RVOT SITE FOR MAPPING. AT RVOT, THE EARLIEST TARGET POINT WAS MAPPED FOR ABLATION (POWER MODE 30W), AND VENTRICULAR PREMATURE DISAPPEARANCE OCCURRED AFTER ABLATION. AFTER VERIFICATION WITH ISOPROTERENOL, HOMOLOGOUS PREMATURE VENTRICULAR TACHYCARDIA STILL EXISTED, AND CONSOLIDATION ABLATION AT THE RVOT SITE WAS INEFFECTIVE. THEREFORE, IT WAS CONSIDERED TO ELIMINATE IT AT THE ADJACENT POSITION OF AORTIC ROOT (AO). PERFORM FEMORAL ARTERY PUNCTURE AND RETROGRADE CATHETERIZATION TO THE BASE OF THE AO SINUS FOR MAPPING AND MAP THE EARLIEST TARGET BETWEEN THE LEFT AND RIGHT SINUSES. PERFORM ABLATION AT THE EARLIEST TARGET SITE (POWER MODE 30W) AND INDUCED WITH SYNCHRONOUS PERIPHERAL INTRAVENOUS INJECTION OF ISOPROTERENOL. DURING THE PROCESS, THE CATHETER WAS LIFTED THREE TIMES AND THE IMPEDANCE RAPIDLY INCREASED. THE RADIOFREQUENCY GENERATOR AUTOMATICALLY CUT OFF THE ABLATION, AND THE OPERATOR ADJUSTED THE POSITION BEFORE PERFORMING ANOTHER CONSOLIDATION ABLATION. AROUND 17:30, IT WAS OBSERVED THAT THE PATIENT'S HEART RATE HAD SLOWED DOWN, PROMPTING THE OPERATOR TO OBSERVE THE PATIENT'S CONDITION. AT THIS TIME, THE PATIENT'S FACE WAS IN A GRAY, PURPLE STATE, AND THE SURGEON CONSIDERED THE PERICARDIUM. THEREFORE, BLOOD PRESSURE WAS MEASURED AGAIN TO OBSERVE OXYGEN SATURATION AND OTHER INDICES, AND X-RAYS WERE USED TO OBSERVE HEARTBEATS. THEY FOUND THAT THE HEARTBEAT WAS WEAK, SO THEY PERFORMED CHEST COMPRESSIONS AND SIMULTANEOUSLY CONTACTED A CORONARY ARTERY DOCTOR TO PERFORM CORONARY ANGIOGRAPHY ON SITE. AFTER THE CORONARY DOCTOR ARRIVED AT THE SITE, A CORONARY ANGIOGRAPHY WAS PERFORMED, AND IT WAS FOUND THAT THERE WAS OCCLUSION IN THE LEFT MAIN ARTERY. THEREFORE, CORONARY STENT IMPLANTATION WAS PERFORMED. AT 18:30, AFTER MULTIPLE ROUNDS OF RESCUE, THE PATIENT ENTERED A STATE OF DEATH AND THE DEATH RESULT WAS ANNOUNCED TO THE PATIENT'S FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603090 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D| L