BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9769744 · Received February 28, 2020

    Report

    Report Number
    2029046-2020-00321
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 4, 2020
    Report Date
    February 4, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SECOND VISUAL INSPECTION WAS COMPLETED, AND IT WAS FOUND THAT THE DISTAL TIP WAS BENT AND PARTIALLY DETACHED. THERE WAS RED COLOR IS OBSERVED UNDER PEBAX AND INTERNAL PARTS WERE EXPOSED. FURTHER TESTING WAS REQUIRED. ON MARCH 2, 2020, A SCANNING ELECTRON MICROSCOPE (SEM) WAS PERFORMED. THE SCANNING ELECTRON MICROSCOPE (SEM) RESULTS SHOWED THAT THE ELECTRODE WAS DETACHED AND LIFTED. THERE WAS NO POLYURETHANE (PU) BORDER OBSERVED ON THE EDGES OF THE ELECTRODE. IT WAS ALSO OBSERVED THAT THERE WAS MECHANICAL DAMAGE AND A HOLE ON THE PEBAX SURFACE. THE ANALYSIS IS STILL IN PROCESS AND IS NOT YET COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURER'S REFERENCE # ==> PC-(B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY = IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER THAT WAS REPORTED TO HAVE A BROKEN TIP. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS CONNECTED TO THE FRONT OF THE PATIENT INTERFACE UNIT (PIU), THE CATHETER DISPLAYED NOISE FROM MAP CHANNELS 3-4 ON THE CARTO® 3 SYSTEM AND RECORDING SYSTEM. THE PHYSICIAN ALWAYS HAD ECG AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. THE CONNECTION WAS ADJUSTED, BUT THE ISSUE REMAINED. THE CABLE WAS REPLACED, AND THE ISSUE PERSISTED. THEN UNDER X-RAY, IT WAS NOTICED THE DISTAL END OF THE CATHETER (AROUND POLE 3-4) HAD AN UNUSUAL CURVE AND THE PLASTIC COVERING OF THE CATHETER WAS RIPPED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED OR ANY LIFTED/SHARP RING. THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY WITHOUT ANY RESISTANCE, THE PHYSICIAN BENT THE TIP EVEN MORE. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND DISTAL TIP WAS BENT AND PARTIALLY DETACHED. A RED COLOR WAS OBSERVED UNDER PEBAX. A SECOND CLOSER INSPECTION WAS PERFORMED, AND IT WAS FOUND THAT THERE WERE INTERNAL PARTS EXPOSED. THE RETURNED DEVICE WAS THEN EVALUATED FOR ELECTRICAL RESISTANCE AND CURRENT LEAKAGE AND IT FAILED ON ELECTRODE. FURTHER EXAMINATION REVEALED THAT THE LEAD WIRE WAS BROKEN CAUSING THE IMPROPER SIGNAL CONDITION. ADDITIONALLY, A SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED AND THE RESULTS SHOWED ELECTRODE DETACHED AND LIFTED. NO POLYURETHANE (PU) BORDER WAS OBSERVED ON THE EDGES OF THE ELECTRODE AND MECHANICAL DAMAGE AND A HOLE ON THE PEBAX SURFACE. THE OBJECT THAT CAUSE THE DAMAGE REMAINS UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30307177M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. THE ROOT CAUSE OF THE WIRE BREAKAGE, BROKEN TIP, PEBAX AND ELECTRODE DAMAGED 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. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    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. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER THAT WAS REPORTED TO HAVE A BROKEN TIP. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS CONNECTED TO THE FRONT OF THE PATIENT INTERFACE UNIT (PIU), THE CATHETER DISPLAYED NOISE FROM MAP CHANNELS 3-4 ON THE CARTO® 3 SYSTEM AND RECORDING SYSTEM. THE PHYSICIAN ALWAYS HAD ECG AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. THE CONNECTION WAS ADJUSTED, BUT THE ISSUE REMAINED. THE CABLE WAS REPLACED, AND THE ISSUE PERSISTED. THEN UNDER X-RAY, IT WAS NOTICED THE DISTAL END OF THE CATHETER (AROUND POLE 3-4) HAD AN UNUSUAL CURVE AND THE PLASTIC COVERING OF THE CATHETER WAS RIPPED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED OR ANY LIFTED/SHARP RING. THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY WITHOUT ANY RESISTANCE, THE PHYSICIAN BENT THE TIP EVEN MORE. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE PHYSICIAN DID NOT REPORT ANY ABNORMAL PRE-SHAPE PRIOR TO THE INTRODUCTION. THE SHEATH USED DURING THE CASE WAS AN ST. JUDE MEDICAL SL0 8.5 FR. NO PATIENT CONSEQUENCES WERE REPORTED. THE BAD/PARTIAL ECG (BS OR IC) ISSUE WAS ASSESSED AS A NOT MDR REPORTABLE ISSUE SINCE THE POTENTIAL RISK THAT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH WAS REMOTE. ON FEBRUARY 22, 2020, THE BIOSENSE WEBSTER, INC PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND UPON INITIAL VISUAL INSPECTION IT WAS NOTED THAT THE DISTAL TIP WAS BENT, PARTIALLY DETACHED AND RED COLOR WAS OBSERVED UNDER PEBAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233707 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30307177M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTO 3 SYSTEM| ST. JUDE MEDICAL SL0 8.5 FR SHEATH