BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 17423684 · Received July 31, 2023

    Report

    Report Number
    17423684
    Event Type
    Other
    Date Received
    July 31, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT #1 [REDACTED DATE]: AFTER PLACEMENT INTO THE PATIENT, THERE WAS AN ERROR MESSAGE REGARDING OVERHEATING OF THE ABLATION CATHETER. THE CATHETER WAS REMOVED WITHOUT INCIDENT OR HARM TO THE PATIENT. CLINICAL SITE NOTIFIED MANUFACTURER DIRECTLY. LOT# 31047115L. EVENT #2 [REDACTED DATE]: THE DISTAL ELECTRODES OF THE ABLATION CATHETER FAILED AFTER PLACEMENT INTO THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITHOUT INCIDENT OR HARM TO THE PATIENT. CLINICAL SITE NOTIFIED MANUFACTURER DIRECTLY. LOT# 31056674L. EVENT #3 [REDACTED DATE]: THERE WAS AN IRRIGATION MALFUNCTION WITH THE ABLATION CATHETER DURING PREP. THE CATHETER WAS REMOVED AND REPLACED WITHOUT HARM TO THE PATIENT. CLINICAL SITE NOTIFIED MANUFACTURER DIRECTLY. LOT# 31020343L. EVENT #4 [REDACTED DATE]: THERE WAS AN INVALID FORCE READING ERROR AFTER THE ABLATION CATHETER WAS PLACED INTO THE PATIENT. THE CATHETER WAS REMOVED AND REPLACE WITHOUT HARM TO THE PATIENT. CLINICAL SITE NOTIFIED MANUFACTURER DIRECTLY. LOT 31016802L. EVENT #5 [REDACTED DATE]: THE DIRECTIONAL MOVEMENT OF THE ABLATION CATHETER MALFUNCTIONED. THE CATHETER WAS REMOVED AND REPLACED WITHOUT HARM TO THE PATIENT. CLINICAL SITE NOTIFIED MANUFACTURER DIRECTLY. LOT# 30994725L. EVENT #6 (B)(6) 2023: DURING PREP, A DEFECTIVE ELECTRODE WAS DISCOVERED. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ABLATION CATHETER. CLINICAL SITE NOTIFIED MANUFACTURER DIRECTLY. LOT# 30966698L. EVENT #7 [REDACTED DATE]: THE ABLATION CATHETER WAS NOT PERFORMING AS EXPECTED AFTER PLACEMENT INTO THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ABLATION CATHETER WITHOUT INCIDENT OR HARM TO THE PATIENT. CLINICAL SITE NOTIFIED MANUFACTURER DIRECTLY. LOT# 30945018L. MANUFACTURER RESPONSE FOR ABLATION CATHETER, THERMOCOOL SMARTTOUCH STSF ABLATION CATHETER (PER SITE REPORTER) CLINICAL SITE NOTIFIED MANUFACTURER REP DIRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645407 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown