BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10015922 · Received April 30, 2020

    Report

    Report Number
    2029046-2020-00587
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    March 24, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, BIOSENSE WEBSTER, INC. (BWI) BECAME AWARE THAT THE MANUFACTURING RECORD EVALUATION (MRE) STATEMENT WAS MISTAKENLY OMITTED FROM THE SUPPLEMENTAL REPORT SUBMITTED ON (B)(6) 2020. THE OMITTED STATEMENT IS AS FOLLOWS: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(6) NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON MAY 6, 2020, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB FOUND A HOLE IN THE PEBAX. INITIALLY, AFTER THE PULMONARY VEIN ISOLATION (PVI), SUPERIOR VENA CAVA (SVC) ISOLATION WAS CONDUCTED. WHEN THEY INSERTED INTO THE LEFT ATRIUM (LA) AGAIN FOR CHECKING THE PVI, THE BACKGROUND FLASHED RED WHEN THE CONTACT FORCE WAS ¿HIGH¿. CONTACT FORCE WAS NOT DISPLAYED. AT FIRST AFTER INSERTION INTO THE PATIENT¿S BODY, IRRIGATION NEVER STOPPED. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY, THE IRRIGATION HOLE OF THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS CHECKED AND RED LIQUID (BLOOD) CAME OUT. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. DEVICE EVALUATION SUMMARY: THE DEVICE WAS VISUALLY INSPECTED, AND THE SHAFT WAS FOUND KINKED WHIT NO EXPOSED WIRES NEXT TO THE HANDLE AND IT WAS FOUND A HOLE AT THE PEBAX AND REDDISH MATERIAL INSIDE IT.. THEN, FORCE SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON PEBAX CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, THE ROOT CAUSE OF THE KINKED SHAFT CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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 · 1

    (B)(6). THE BWI 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB FOUND A HOLE IN THE PEBAX. INITIALLY, AFTER THE PULMONARY VEIN ISOLATION (PVI), SUPERIOR VENA CAVA (SVC) ISOLATION WAS CONDUCTED. WHEN THEY INSERTED INTO THE LEFT ATRIUM (LA) AGAIN FOR CHECKING THE PVI, THE BACKGROUND FLASHED RED WHEN THE CONTACT FORCE WAS ¿HIGH¿. CONTACT FORCE WAS NOT DISPLAYED. AT FIRST AFTER INSERTED INTO THE PATIENT¿S BODY, IRRIGATION NEVER STOPPED. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY, THE IRRIGATION HOLE OF THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS CHECKED AND RED LIQUID (BLOOD) CAME OUT. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE HIGH FORCE AND THE CONTACT FORCE NOT DISPLAYING WERE ASSESSED AS NOT REPORTABLE. THESE ISSUES WERE HIGHLY DETECTABLE WHEN OCCURRING. THE POTENTIAL THAT THEY COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS LOW. THE ISSUE OF THE RED LIQUID (BLOOD) CAME OUT WAS ASSESSED AS FOREIGN MATERIAL INSIDE THE PEBAX. THE FOREIGN MATERIAL INSIDE THE PEBAX WAS ASSESSED AS A NOT REPORTABLE ISSUE. THERE WAS NO DAMAGE REPORTED TO THE PEBAX INTEGRITY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE BIOSENSE WEBSTER, INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND ON APRIL 10, 2020 NOTED IT WAS RETURNED IN THE CONDITION REPORTED AS THERE WAS REDDISH MATERIAL INSIDE THE PEBAX. IN ADDITION, A KINK WAS NOTE ON THE SHAFT. THE REDDISH MATERIAL INSIDE THE PEBAX REMAINS ASSESSED AS NOT REPORTABLE. THE KINK ON THE SHAFT WAS ALSO ASSESSED AS NOT REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT WAS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE (BWI) PRODUCT ANALYSIS LAB FOUND DURING ADDITIONAL ANALYSIS ON APRIL 21, 2020, A HOLE IN THE PEBAX AND REDDISH MATERIAL INSIDE OF IT. THE HOLE IN THE PEBAX WAS ASSESSED AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS APRIL 21, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479459 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30317615M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BRAND CATHETER