BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 5769815 · Received July 5, 2016

    Report

    Report Number
    9673241-2016-00424
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Date of Event
    November 30, 2015
    Report Date
    November 30, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMARTTOUCH APPROVED UNDER P030031/S053. (B)(4). THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND CRYSTALIZED WHITE MATERIAL WAS FOUND AT THE PEBAX AREA. PER THIS CONDITION A SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED OVER THIS AREA OF THE CATHETER AND IT WAS FOUND THAT THERE WAS EVIDENCE OF SCRATCHING AND RUPTURE INDUCED BY AN UNKNOWN OBJECT. THE SCRATCHING AND RUPTURE CONDITIONS CONTRIBUTED TO THE FILTRATION OF THE CLEAR MATERIAL OBSERVED DURING THE VISUAL INSPECTION. THE RETURNED DEVICE WAS THEN EVALUATED FOR ELECTRICAL RESISTANCE AND THE THERMOCOUPLE TEST AND CATHETER FAILED. CURRENT LEAKAGE WAS OBSERVED ON ELECTRODE #1 AND THERMOCOUPLE TEST FAILED. FURTHER EXAMINATION REVEALED THAT THE THERMOCOUPLE WIRES WERE BROKEN AT THE TIP SECTION CREATING AN INTERMITTENCE OF TEMPERATURE. THE CURRENT LEAKAGE OBSERVED ON ELECTRODE #1 MIGHT BE RELATED TO THE CRYSTALIZED MATERIAL OBSERVED AT THE PEBAX AREA. 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. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE TC BREAKAGE ON THE TIP SECTION FOR SMART TOUCH AND SMART TOUCH SF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL SF CATHETER. INITIALLY WHEN CREATING THE MAP, THEY NOTICED THAT THE TEMPERATURE WAS NO LONGER POSSIBLE TO READ. FIRST THEY TRIED TO CHANGE THE INTERFACE CABLE WITH NO EFFECT. CHANGING THE CATHETER RESOLVED THE PROBLEM. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS TEMPERATURE ISSUE IS NON-INDICATIVE OF AN MDR REPORTABLE EVENT AS THE ABLATION CANNOT BE PERFORMED. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE CATHETER FOR ANALYSIS AND DISCOVERED ON JUNE 15, 2016 DURING THE SCANNING ELECTRON MICROSCOPE (SEM) TESTING THAT THE PEBAX WAS DAMAGED AS THERE WAS EVIDENCE OF SCRATCHING AND RUPTURE. THIS CONDITION WAS NOT NOTICED BY THE ACCOUNT. THE PHYSICIAN DID NOT FEEL ANY RESISTANCE WHILE INTRODUCING OR RETRACTING THE CATHETER FROM THE ST JUDE MEDICAL SL1 8.5F SHEATH. IT WAS CONFIRMED THAT THERE WAS NO PATIENT CONSEQUENCE. SINCE THE INTEGRITY OF THE CATHETER HAS BEEN COMPROMISED, THIS RETURNED CATHETER CONDITION HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION. THEREFORE, THE AWARENESS DATE HAS BEEN RESET TO JUNE 15, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424449 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17175074L

    Patients

    Seq Age Sex Outcome Treatment
    1