BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16616755 · Received March 26, 2023

    Report

    Report Number
    2029046-2023-00634
    Event Type
    Malfunction
    Date Received
    March 26, 2023
    Date of Event
    October 31, 2022
    Report Date
    March 25, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). THE INVESTIGATION WAS COMPLETED ON 27-FEB-2023. A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING BIOSENSE WEBSTER'S PROCEDURES. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, BLOOD WAS OBSERVED INSIDE THE PEBAX OF THE CATHETER, NO EXTERNAL DAMAGE WAS OBSERVED ON THE PEBAX, NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED ON THE PICTURE PROVIDED. THE BLOOD INSIDE THE PEBAX COULD BE RELATED TO THE FORCE ISSUE REPORTED BY THE CUSTOMER, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE PRODUCT ANALYSIS WAS PERFORMED AS APPROPRIATE IN ORDER TO FIND THE ROOT CAUSE OF THE COMPLAINT. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND SCREENING TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THERE WAS A REDDISH MATERIAL AND A HOLE INSIDE THE PEBAX, NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED. THE MAGNETIC AND FORCE FEATURE WERE TESTED AND NO ERRORS WERE OBSERVED. THE FORCE VALUES AND THE VECTOR WERE OBSERVED WITHIN SPECIFICATIONS. NO FORCE ISSUES WERE OBSERVED. HOWEVER, THE REDDISH MATERIAL FOUND COULD BE RELATED TO THE FORCE ISSUE REPORTED BY THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUES REPORTED BY THE CUSTOMER WERE CONFIRMED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFORMATION THAT SHOULD BE CONSIDERED: TO ENSURE ACCURATE FORCE READINGS, VERIFY THAT THE FORCE READING IS NEAR ZERO WHEN THE CATHETER IS NOT IN CONTACT WITH TISSUE. IF THE FORCE READING IS NOT NEAR ZERO WHEN THE CATHETER IS NOT IN CONTACT WITH TISSUE, PERFORM ZEROING. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: APPROPRIATE TERM/CODE NOT AVAILABLE (C22)/ INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) WERE SELECTED AS RELATED TO THE PICTURE PROVIDED. INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿FORCE ISSUE¿ AND ¿FOREIGN MATERIAL INSIDE THE PEBAX WITH NO EXTERNAL DAMAGE¿ ISSUES AND THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE REDDISH MATERIAL AND A HOLE INSIDE THE PEBAX. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE INSIDE THE PEBAX.. INITIALLY IT WAS REPORTED THAT THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER BEGAN TO INDICATE TO MUCH CONTACT FORCE AT 10G (BLINKING RED). AFTER INSPECTION, IT WAS DISCOVERED THAT THERE WAS A BLOOD LEAKAGE IN A PRECISION SPRING COMPARTMENT. THE CATHETER WAS REPLACED WITH A NEW ONE. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO NOTICEABLE DAMAGE ON THE PEBAX. THE ABBOTT AGILIS SHEATH (SIZE UNKNOWN, BUT IT WAS REGULARLY USED WITH THE TC ST SF CATHETER. NO DIFFICULTIES WERE NOTICED DURING CATHETER ADVANCE, IN THAT SHORT TIME OF USE OR WHILE WITHDRAWING. THE FORCE ISSUE WAS ASSESSED AS NON REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BLOOD LEAKAGE IN A PRECISION SPRING COMPARTMENT ISSUE WAS ASSESSED AS NON REPORTABLE FOR FOREIGN MATERIAL INSIDE THE PEBAX WITH NO EXTERNAL DAMAGE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 27-FEB-2023 THERE WAS A REDDISH MATERIAL AND A HOLE INSIDE THE PEBAX.. THE HOLE ON THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 27-FEB-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378290 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30875211L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female NON BWI-ABBOTT AGILIS SHEATH.| UNKNOWN BRAND CATHETER.