BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11449160 · Received March 9, 2021

    Report

    Report Number
    2029046-2021-00274
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 10, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    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) 2021, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE, ERROR 8 APPEARED AFTER THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS CONNECTED. THE CABLE OTHER THAN THE PATCH UNIT IN FRONT OF THE PIU WAS DISCONNECTED BUT THE ISSUE WAS NOT RESOLVED. THE CABLE WAS REPLACED WITH AN ABLATION CATHETER AND ERROR 8 RESOLVED WITH A PATIENT INTERFACE UNIT (PIU) REBOOT. THE PACING LEADS WERE CONNECTED TO THE PRIMARY PACING PORT. THE PRIMARY PORT DID NOT ALLOW TO PACE AND ABLATE AT THE SAME TIME; HOWEVER, UNWANTED PACING WAS BEING DELIVERED. NO PATIENT CONSEQUENCES REPORTED. DEVICE EVALUATION DETAILS: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE SMART TOUCH BIDIRECTIONAL SF CATHETER. AN ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [30438391M] NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING STATED IN THE CARTO 3 SYSTEM MANUAL: AN ERROR WAS DETECTED IN THE STIMULATION ROUTING HARDWARE OF THE PATIENT INTERFACE UNIT (PIU). WHEN POSSIBLE, PERFORM THE FOLLOWING TO DETERMINE IF THE PROBLEM WAS CAUSED BY THE PIU, OR BY ONE OF THE CATHETERS OR THEIR EXTENSION CABLES: 1. DISCONNECT ALL CATHETERS AND CATHETER EXTENSION CABLES FROM THE PIU SOCKETS. 2. SWITCH THE PIU POWER SUPPLY OFF AND ON AGAIN. 3. WAIT A FEW MINUTES FOR COMMUNICATION TO BE ESTABLISHED BETWEEN THE PIU AND THE WORKSTATION. 4. IF THE PROBLEM PERSISTS, CONTACT BIOSENSE WEBSTER SERVICE AND SUPPORT DEPARTMENT. 5. IF THE PROBLEM HAS DISAPPEARED, RECONNECT EACH CABLE AND CATHETER, ONE BY ONE, AND CHECK IF THE ERROR RE-APPEARS AFTER A PARTICULAR CABLE OR CATHETER CONNECTION. 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

    ON 5/21/2021, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. ERROR 8 OCCURRED, DURING RESOLVED, ERROR 139 OCCURRED. AFTER ABOUT 2 HOURS SINCE THE PROCEDURE WAS STARTED, AFTER 5 MINUTES SINCE THE CATHETER WAS USED (RIGHT AFTER THE ABLATION CATHETER WAS INSERTED INTO THE CARDIAC CAVITY). THE CABLE OTHER THAN THE PATCH UNIT IN FRONT OF THE PATIENT INTERFACE UNIT (PIU) WAS DISCONNECTED BUT NOT RESOLVED, AFTER ABLATION CATHETER WAS CONNECTED, ERROR, SO AS A PRECAUTION, THE CABLE WAS REPLACED WITH AN ABLATION CATHETER AND ERROR 8 RESOLVED WITH A PIU REBOOT. AN ERROR 139 OCCURRED WHEN CABLES WERE INSERTED INTO THE FRONT OF THE PIU ONE BY ONE. ALTHOUGH THE CABLE OF THE LASSO WAS REPLACED BUT THE ISSUE CONTINUED, CATHETER WAS CHANGED BUT THE ISSUE CONTINUED, THE ERROR WAS RESOLVED WHEN THE ADAPTER WAS REPLACED AS A PRECAUTION. THE PROCEDURE WAS CONTINUED AND ENDED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. 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). 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 · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE, ERROR 8 APPEARED AFTER THE THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER WAS CONNECTED. THE CABLE OTHER THAN THE PATCH UNIT IN FRONT OF THE PIU WAS DISCONNECTED BUT THE ISSUE WAS NOT RESOLVED. THE CABLE WAS REPLACED WITH AN ABLATION CATHETER AND ERROR 8 RESOLVED WITH A PIU REBOOT. THE PACING LEADS WERE CONNECTED TO THE PRIMARY PACING PORT. THE PRIMARY PORT DID NOT ALLOW TO PACE AND ABLATE AT THE SAME TIME; HOWEVER, UNWANTED PACING WAS BEING DELIVERED. NO PATIENT CONSEQUENCES REPORTED. THE MAGNETIC SENSOR ERROR IS NOT MDR-REPORTABLE. THE UNWANTED PACING IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343608 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 30438391M 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 LASSO NAV| UNSPECIFIED CATHETER CABLE