BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19503727 · Received June 10, 2024

    Report

    Report Number
    2029046-2024-01886
    Event Type
    Death
    Date Received
    June 10, 2024
    Date of Event
    May 15, 2024
    Report Date
    July 29, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT RESULTED IN DEATH. THE PHYSICIAN MAY HAVE HEARD A STEAM POP AND IMMEDIATELY HAD THE TECH COME OFF ABLATION. WITHIN A MINUTE, ANESTHESIA NOTICED THAT THE BLOOD PRESSURE DROPPED. THE PATIENT ENDED UP CODING. THEY WERE NOT ABLE TO GET THE PATIENT BACK AND THE PATIENT PASSED AWAY. THE PHYSICIAN IS NOT A HUNDRED PERCENT SURE THAT HE HEARD THE STEAM POP OR NOT, BUT HE BELIEVED THAT THERE WAS A PERFORATION WITH THE STEAM POP. WHEN THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE SAW THE PATIENT'S BLOOD PRESSURE, IT WAS 34/14. THEY DID NOT HAVE AN INTRACARDIAC ULTRASOUND IN. THEY JUST HAD VASCULAR ULTRASOUND AVAILABLE. THE PHYSICIAN CALLED FOR A STAT ECHO TECH TO COME IN, HOWEVER, HE WAS ALREADY AWAY FROM THE HOSPITAL. THE PHYSICIAN DID NOT CONFIRM WITH A CARDIAC ULTRASOUND. HE ENDED UP OPENING A PERICARDIOCENTESIS TRAY AND ENDED UP PULLING ABOUT 400ML OF BLOOD, SO THAT'S WHERE HE BELIEVED THAT HE ENDED UP HAVING A PERFORATION. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN IS UNSURE ABOUT THE CAUSE OF DEATH. THE PHYSICIAN BELIEVED IT MAY HAVE BEEN UNDERLYING PATIENT CONDITION. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE WERE NO ERRORS REPORTED BY THE BIOSENSE WEBSTER SYSTEMS. UNKNOWN INFORMATION REGARDING STEAM POP DETAILS. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31265835L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE PHYSICIAN WAS UNSURE ABOUT THE CAUSE OF DEATH, BUT BELIEVED IT MAY HAVE BEEN UNDERLYING PATIENT CONDITION. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNING AND PRECAUTIONS: WHEN USING THE CATHETER WITH CONVENTIONAL SYSTEMS (USING FLUOROSCOPY TO DETERMINE CATHETER TIP LOCATION), OR WITH THE CARTO¿ 3 SYSTEM, CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED. THE FIRMNESS OF THE BRAIDED TIP DICTATES THAT CARE MUST BE TAKEN TO PREVENT PERFORATION OF THE HEART. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CORRECTION: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT RESULTED IN DEATH. THE PHYSICIAN MAY HAVE HEARD A STEAM POP AND IMMEDIATELY HAD THE TECH COME OFF ABLATION. WITHIN A MINUTE, ANESTHESIA NOTICED THAT THE BLOOD PRESSURE DROPPED. THE PATIENT ENDED UP CODING. THEY WERE NOT ABLE TO GET THE PATIENT BACK AND THE PATIENT PASSED AWAY. THE PHYSICIAN IS NOT A HUNDRED PERCENT SURE THAT HE HEARD THE STEAM POP OR NOT, BUT HE BELIEVED THAT THERE WAS A PERFORATION WITH THE STEAM POP. WHEN THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE SAW THE PATIENT'S BLOOD PRESSURE, IT WAS 34/14. THEY DID NOT HAVE AN INTRACARDIAC ULTRASOUND IN. THEY JUST HAD VASCULAR ULTRASOUND AVAILABLE. THE PHYSICIAN CALLED FOR A STAT ECHO TECH TO COME IN, HOWEVER, HE WAS ALREADY AWAY FROM THE HOSPITAL. THE PHYSICIAN DID NOT CONFIRM WITH A CARDIAC ULTRASOUND. HE ENDED UP OPENING A PERICARDIOCENTESIS TRAY AND ENDED UP PULLING ABOUT 400ML OF BLOOD, SO THAT'S WHERE HE BELIEVED THAT HE ENDED UP HAVING A PERFORATION. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN IS UNSURE ABOUT THE CAUSE OF DEATH. THE PHYSICIAN BELIEVED IT MAY HAVE BEEN UNDERLYING PATIENT CONDITION. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE WERE NO ERRORS REPORTED BY THE BIOSENSE WEBSTER SYSTEMS. UNKNOWN INFORMATION REGARDING STEAM POP DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13132 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31265835L

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death| L| R NGEN RF GENERATOR, US| UNKNOWN ANESTHESIA MACHINE| UNKNOWN IRRIGATION PUMP| UNK_CARTO 3