BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8401924 · Received March 7, 2019

    Report

    Report Number
    2029046-2019-02762
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 11, 2019
    Report Date
    February 11, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS CREATED TO REPORT THE WRONG PRODUCT THAT WAS RECEIVED UNDER ANOTHER COMPLAINT THAT DID NOT MATCH. BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WHICH WAS IDENTIFIED TO HAVE A HOLE IN THE PEBAX SLEEVE EXPOSING METAL, REDDISH MATERIAL INSIDE, AND THE TIP DOME LIGHTLY SCRATCHED. ON 3/11/2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. MANUFACTURER REF NO: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS CREATED TO REPORT THE WRONG PRODUCT THAT WAS RECEIVED UNDER ANOTHER COMPLAINT THAT DID NOT MATCH. BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WHICH WAS IDENTIFIED TO HAVE A HOLE IN THE PEBAX SLEEVE EXPOSING METAL, REDDISH MATERIAL INSIDE, AND THE TIP DOME LIGHTLY SCRATCHED. THE INVESTIGATIONAL ANALYSIS COMPLETED 4/9/2019. THE DEVICE WAS VISUALLY INSPECTED AND A HOLE IN THE PEBAX WAS OBSERVED WITH REDDISH MATERIAL INSIDE. SOME LIGHT SCRATCHES WERE OBSERVED ON THE TIP DOME. DEFLECTION TESTING WAS PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS DEFLECTING CORRECTLY. ELECTRICAL TESTING WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTIONS WERE OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THE MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER FAILED. ERROR 105 AND 106 WERE OBSERVED. A FAILURE ANALYSIS WAS PERFORMED BY DISSECTING THE HANDLE AND CORROSION WAS FOUND ON THE PC BOARD. THE CATHETER WAS DISSECTED ON THE TIP AREA. LOSS OF ELECTRICAL CONTINUITY AT THE SENSOR WAS FOUND. IT WAS DETERMINED THAT THE ROOT CAUSE WAS INTERNAL FAILURE OF THE SENSOR. DUE TO THE OBSERVED CORROSION, THE CATHETER WAS CONNECTED TO THE COOL FLOW PUMP. WATER LEAKAGE WAS OBSERVED. THE CATHETER DISSECTION AT THE TIP AREA WAS PERFORMED AND THE IRRIGATION TUBING WAS FOUND BROKEN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE ROOT CAUSE OF THE DAMAGE ON PEBAX AND THE DAMAGE ON THE IRRIGATION TUBE 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. THE ROOT CAUSE OF THE INTERNAL FAILURE OF THE SENSOR CANNOT BE DETERMINED. HOWEVER, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. MANUFACTURE REF NO: (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. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT WAS CREATED TO REPORT THE WRONG PRODUCT THAT WAS RECEIVED UNDER ANOTHER COMPLAINT THAT DID NOT MATCH. ON 2/11/2019, BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WHICH WAS IDENTIFIED TO HAVE A HOLE IN THE PEBAX SLEEVE EXPOSING METAL, REDDISH MATERIAL INSIDE, AND THE TIP DOME LIGHTLY SCRATCHED. THE REDDISH MATERIAL AND LIGHTLY SCRATCHED TIP DOME HAS BEEN ASSESSED AS NOT REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE HOLE IN THE PEBAX WITH EXPOSED METAL HAS BEEN ASSESSED AS MDR REPORTABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION FOR THE WRONG PRODUCT RECEIVED. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. A NEW COMPLAINT WAS CREATED TO INVESTIGATE AND REPORT THE MALFUNCTION FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193646 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30121571L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1