BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTABLATE¿ SYSTEM RF GENERATOR (US)

    MDR report key: 12858283 · Received November 22, 2021

    Report

    Report Number
    2029046-2021-50012
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 22, 2021
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    UDI-DI
    04260166371390
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: MANUFACTURE REPORT NUMBER # 2029046-2021-01862 FOR PRODUCT CODE (B)(4) (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER) . IMPORTER REPORT NUMBER. PRODUCT CODE (B)(4) (SMARTABLATE¿ SYSTEM RF GENERATOR (US))

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 60 -70 YEAR-OLD MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US AND THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT (CVA). AFTER THE AFIB PROCEDURE WAS COMPLETED, THE PATIENT HAD "STROKE-LIKE" SYMPTOMS WHEN WAKING UP FROM ANESTHESIA. THE CALLER STATED THAT THE PATIENT PRESENTED A FLACCID LEFT SIDE OF THE BODY UPON WAKING UP. A CT WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO ST LOUIS UNIVERSITY HOSPITAL FOR FURTHER TREATMENT. THERE ALSO WAS CHAR FOUND ON THE CATHETER TIP AND CLEANED OFF DURING THE PROCEDURE. AT THE TIME OF THE EVENT, THE PHYSICIAN STATED THAT WE HAD NOT DONE ANYTHING DIFFERENT FROM HER WORKFLOW. HOWEVER, WE WERE TOLD THE NEXT DAY BY A VA RN THAT THE SMARTABLATE REMOTE SETTING IN THE CONTROL BOOTH HAD BEEN ON THE 4MM CATHETER PRIOR TO THE CHAR BEING FOUND AT THE CATHETER TIP. ONCE THE CHAR WAS CLEANED OFF, THE TIP WAS FLUSHED, AND THE CATHETER READVANCED TO LEFT ATRIUM, THE RN IN THE CONTROL BOOTH CHANGED THE SMARTABLATE SETTING TO STSF. NEITHER THE PHYSICIAN NOR I WERE TOLD THAT THE CASE HAD STARTED WITH INCORRECT SETTINGS AT THAT TIME. CT WAS PERFORMED AT THE VA. PT WAS TRANSFERRED TO ST LOUIS UNIVERSITY HOSPITAL FOR POSSIBLE INTERVENTION AND MONITORING. BASED ON PT CONDITION, SLUH CHOSE NOT TO INTERVENE. PATIENT OUTCOME OF THE ADVERSE EVENT: IMPROVED. DEVICE INVESTIGATION DETAILS: THE DEVICE INVESTIGATION HAS BEEN COMPLETED ON 10-FEB-2022. THE INVESTIGATION WHICH INCLUDED A MANUFACTURING RECORD EVALUATION (MRE). THE MRE WAS PERFORMED FOR THE FINISHED DEVICE G4C-2491 NUMBER, AND INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT WAS FOUND DURING THE REVIEW. REPAIR FOLLOW-UP WAS PERFORMED AS THE DEVICE WAS NOT SHIPPED BACK FOR SERVICE OR REPAIR. SERVICE WAS DECLINED BY THE CUSTOMER. AS SUCH, THE REPORTED COMPLAINT CANNOT BE CONFIRMED. 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 (B)(6) MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED A CVA. AFTER THE AFIB PROCEDURE WAS COMPLETED, THE PATIENT HAD "STROKE-LIKE" SYMPTOMS WHEN WAKING UP FROM ANESTHESIA. THE CALLER STATED THAT THE PATIENT PRESENTED A FLACCID LEFT SIDE OF THE BODY UPON WAKING UP. A CT WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO ST LOUIS UNIVERSITY HOSPITAL FOR FURTHER TREATMENT. THERE ALSO WAS CHAR FOUND ON THE CATHETER TIP AND CLEANED OFF DURING THE PROCEDURE. ADDITIONAL INFORMATION: THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: UNKNOWN. AT THE TIME OF THE EVENT, THE PHYSICIAN STATED THAT WE HAD NOT DONE ANYTHING DIFFERENT FROM HER WORKFLOW. HOWEVER, WE WERE TOLD THE NEXT DAY BY A VA RN THAT THE SMARTABLATE REMOTE SETTING IN THE CONTROL BOOTH HAD BEEN ON THE 4MM CATHETER PRIOR TO THE CHAR BEING FOUND AT THE CATHETER TIP. ONCE THE CHAR WAS CLEANED OFF, THE TIP WAS FLUSHED, AND THE CATHETER READVANCED TO LEFT ATRIUM, THE RN IN THE CONTROL BOOTH CHANGED THE SMARTABLATE SETTING TO STSF. NEITHER THE PHYSICIAN NOR I WERE TOLD THAT THE CASE HAD STARTED WITH INCORRECT SETTINGS AT THAT TIME. CT WAS PERFORMED AT THE VA. PT WAS TRANSFERRED TO ST LOUIS UNIVERSITY HOSPITAL FOR POSSIBLE INTERVENTION AND MONITORING. BASED ON PT CONDITION, SLUH CHOSE NOT TO INTERVENE. PATIENT OUTCOME OF THE ADVERSE EVENT: IMPROVED REPORTED ON (B)(6) 2021. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. GENERATOR INFORMATION: SMARTABLATE. NO EVIDENCE OF BLOOD THROMBUS / CLOT DURING THE PROCEDURE, BUT CHAR WAS FOUND ON THE TIP OF THE STSF CATHETER AFTER RF ABLATION TERMINATED DUE TO IMPEDANCE SPIKE. CHAR WAS REMOVED AND CATHETER WAS FLUSHED. VIGOROUS SPRAY OBSERVED BEFORE CATHETER REINSERTED AND CASE CONTINUED. THE CORRECT CATHETER SETTINGS WERE NOT SELECTED ON THE GENERATOR: PRIOR TO CHAR OBSERVATION. EMPLOYEE IN CHARGE OF REMOTE CHANGED SETTING TO POWER MODE BUT DID NOT TELL CAS OR PHYSICIAN THAT DAY. PUMP SET AT 2ML PER MINUTE AT START OF CASE. PUMP CHANGED FROM LOW TO HIGH FLOW WITH POWER MODE. NO ERROR MESSAGES AND THE PHYSICIAN/USER DID NOT SEE ANY PRODUCT PROBLEM. NO ISSUES RELATED TO TEMPERATURE AND FLOW ON THE CATHETER. TEMPERATURE, IMPEDANCE AND POWER ARE UNKNOWN: PHYSICIAN ABLATES AT 30 WATTS ON THE POSTERIOR WALL AND 35 WATTS ANTERIORLY. THE PATIENT WAS ANTICOAGULATED, THE ACT 350. PHYSICIAN CHECKS ACTS FREQUENTLY. PUMP INFORMATION: SMARTABLATE PUMP. NO ABLATION WAS GREATER THAN 60 SECONDS. PHYSICIAN USUALLY ABLATES NO LONGER THAN 20 SECONDS IN ON SPOT. THE AVERAGE CONTACT FORCE WAS NOT GREATER THAN 40 GRAMS AND WAS NOT GREATER THAN 25 GRAMS. THERE WERE NO ABLATIONS THAT USED FORCED ABOVE 40 G FOR ANY EXTENDED PERIODS OF TIME. IRRIGATION RATE USED WAS NOT OUTSIDE OF THOSE PRESCRIBED. PRE-ABLATION HIGH SETTING: 15ML PER MINUTE FOR STSF SETTINGS. HEPARINIZED NORMAL SALINE WAS USED AS THE IRRIGATION FLUID. CARTO VISITAG MODULE SETTINGS: RESPIRATION SETTING, STABILITY RANGE, STABILITY TIME, FORCE OVER TIME, & TAG SIZE: RESP GATED, 2.5MM, 5 SEC, FTI 100-300 GAUSS, 3 MM WITH COLOR OPTIONS USED PROSPECTIVELY: FTI. BASED ON THE INFORMATION RECEIVED ON (B)(6) 2021 IT WAS DECIDED TO REPORT THE ADVERSE EVENT UNDER THE SMARTABLATE GENERATOR SINCE THE CONTRIBUTION OF THE CLINICAL USER ERROR OF "INCORRECT CATHETER SETTINGS SELECTION" TO THE PATIENT CONSEQUENCE CANNOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755535 SMARTABLATE¿ SYSTEM RF GENERATOR (US) CARDIAC ABLATION PERCUTANEOUS CATHETER LPB STOCKERT GMBH M490007 04260166371390

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| H SMARTABLATE GENERATOR SPARE-US| SMARTABLATE PUMP KIT-US| THMCL SMTCH SF BID, TC, D-F| UNK_CARTO 3