BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6070690 · Received November 1, 2016

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    Report

    Report Number
    9673241-2016-00757
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    May 20, 2016
    Report Date
    May 20, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE 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. MFR REF NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 11/4/2016, ADDITIONAL INFORMATION REGARDING THIS COMPLAINT WAS RECEIVED: THE CATHETER WAS NOT WITHDRAWN WITH ANY DIFFICULTY THAT MAY HAVE CAUSED THE DAMAGED OBSERVED. DAMAGE WAS NOT OBSERVED PRIOR TO USE, AFTER REMOVAL, OR BEFORE RETURN OF THE CATHETER. CONCOMITANT PRODUCTS: ST. JUDE MEDICAL AGILIS 9FR SHEATH, MODEL AND LOT NUMBERS UNKNOWN. MANUFACTURERS¿ REFERENCE NUMBER: (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL CATHETER WHERE THE TEMPERATURE READINGS WERE EITHER ERRATIC OR MISSING. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND A RUPTURE WAS OBSERVED NEAR THE TIP AREA. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED OVER THE EXTERNAL SURFACE OF THE TIP, AND THE AREA WAS FOUND TO EXHIBIT EVIDENCE OF SCRATCHES AND A PINHOLE, INDUCED BY AN UNKNOWN OBJECT. SALINE SOLUTION RESIDUE WAS ALSO OBSERVED. FURTHER INFORMATION RECEIVED INDICATES THAT CATHETER DAMAGE WAS NOT NOTICED PRIOR TO SENDING THE CATHETER BACK. THE CATHETER CAN BE DAMAGED DURING RETURN TO BWI FOR ANALYSIS. PER THE EVENT, THE RETURNED DEVICE WAS THEN EVALUATED FOR ELECTRICAL RESISTANCE AND SUBJECTED TO A THERMOCOUPLE TEST, WHICH THE CATHETER FAILED. THERE WAS NO LEAKAGE OBSERVED ON THE THERMOCOUPLE WIRES, BUT ELECTRODE #5 EXHIBITED LEAKAGE. ADDITIONALLY, NO READINGS WERE AVAILABLE ON ELECTRODE #5. FURTHER EXAMINATION REVEALED THAT THE THERMOCOUPLE HAD A LOSS OF ELECTRICAL CONTINUITY AT THE TIP AREA NEAR THE DOME. THE ELECTRICAL WIRE OF ELECTRODE #5, AS WELL AS THE IRRIGATION TUBING, WERE FOUND BROKEN AT THE DAMAGED TIP AREA. THE BREAKAGE MAY HAVE CONTRIBUTED TO THE SALINE SOLUTION RESIDUES OBSERVED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. ACCORDING TO THE INFORMATION RECEIVED, THE CATHETER TIP RUPTURE THAT CONTRIBUTED TO THE ELECTRICAL WIRE AND IRRIGATION TUBING DAMAGE MAY HAVE HAPPENED WHILE RETURNING THE CATHETER TO BWI. DURING THE MANUFACTURING PROCESS, ALL CATHETERS ARE INSPECTED FOR VISUAL DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL CATHETER WHERE THE TEMPERATURE READINGS WERE EITHER ERRATIC OR MISSING. THE TEMPERATURE READINGS WERE UNSTABLE REGARDLESS OF WHETHER OR NOT RADIOFREQUENCY (RF) ENERGY WAS BEING DELIVERED. TWO CABLE CHANGES WERE ATTEMPTED, BUT THIS DID NOT RESOLVE THE ISSUE. ULTIMATELY, THE CATHETER ITSELF WAS CHANGED, WHICH DID RESOLVE THE ISSUE. THE CASE WAS THEN COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. THE GENERATOR WAS BEING USED IN POWER CONTROL MODE AT 30W WITH A TEMPERATURE CUTOFF OF 50 DEGREES C AND IMPEDANCE VALUES FROM 120-130 OHMS. THE TEMPERATURE READING WAS ERRATIC AND READ ANYWHERE FROM 27-100 DEGREES C. AS A RESULT, ABLATION WAS NEVER ABLE TO BE STARTED WITH THE SUSPECT CATHETER. ON (B)(6) 2016, THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB FOUND THAT THERE WAS A HOLE 52MM FROM THE CATHETER DOME TIP, AS WELL AS SMALL CRYSTALS AND A YELLOWISH STAIN NEAR THE HOLE. IF THE CATHETER INTEGRITY IS NOT MAINTAINED, THE RISK OF EXPOSURE TO THE CATHETER¿S INTERNAL COMPONENTS INCREASES THE LIKELIHOOD OF THROMBUS IN THE PATIENT. ADDITIONALLY, THE PRESENT OF FOREIGN MATERIAL INCREASES THE RISK OF EMBOLISM AND/OR STROKE. AS A RESULT, THIS LAB FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722690 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17435627M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1