BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4241970 · Received November 10, 2014

    Report

    Report Number
    9673241-2014-00466
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY: (B)(4) IT WAS REPORTED THAT THE CATHETER WITH CATALOG # D132705 WAS NOT IRRIGATING PROPERLY AND THAT THE TEMPERATURE WAS NOT COOLING DOWN. IT WAS STATED THAT WHEN THEY TOOK THE CATHETER OUT, THEY ARE NOT GETTING THE 5 SPRINKLER OR THE MAXIMUM FLOW. THE CATHETER WAS EXCHANGED WITH CATHETER D132704. HEART BLOCK WAS SEEN ON THE RECORDING SYSTEM WITH NO AV CONNECTIONS AFTER EXCHANGING THE CATHETER. VENTRICLE PACING WAS DONE AND THE PATIENT WILL UNDERGO BI-VENTRICULAR ICD FOR NEXT DAY. THE PATIENT WAS STABLE. THE CUSTOMER REPORTED THAT THE PHYSICIAN LOOK BACK ON THE RECORD OF THE RECORDING SYSTEM AND SAID THAT THE CATHETER D132705 MAY HAVE BEEN ON THE PATIENT'S BODY WHEN THE HEART BLOCK OCCURRED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE HE CATHETER WAS ALSO EVALUATED FOR, CARTO 3, AND BIOSENSOR FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. FINALLY AN IRRIGATION TEST WAS PERFORMED AND A WATER LEAKAGE WAS OBSERVED IN THE HANDLE AREA. CATHETER WAS DISSECTED AND IT WAS FOUND THAT THE SHAFT AND THE IRRIGATION TUBE WERE BROKEN. IT APPEARS THAT THE SHAFT BROKE AND ATTEMPTS TO MANIPULATED THE CATHETER APPLIED PRESSURE TO THE IRRIGATION TUBE CAUSING THE OBSERVED CONDITION. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED AND AVOID TWISTING THE CATHETER TO PREVENT ANY DAMAGE. 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 REGARDING THE IRRIGATION ISSUE HAS BEEN VERIFIED. HOWEVER THE ROOT CAUSE OF THE HEART BLOCK REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. IN ADDITION, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THE THERMOCOOL SMART TOUCH BROKEN SHAFT ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BWI EQUIPMENTS INVOLVED WERE: CARTO 3 SYSTEM (SERIAL# (B)(4)), STOCKERT GENERATOR (SERIAL# (B)(4)), COOLFLOW PUMP (SERIAL# (B)(4)), CATHETER D128210 (LOT#17088960L), AND CATHETER SNDSTR10 (SERIAL# (B)(4)). (B)(4) ARE RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WITH CATALOG # D132705 WAS NOT IRRIGATING PROPERLY AND THAT THE TEMPERATURE WAS NOT COOLING DOWN. IT WAS STATED THAT WHEN THEY TOOK THE CATHETER OUT, THEY ARE NOT GETTING THE 5 SPRINKLER OR THE MAXIMUM FLOW. THE CATHETER WAS EXCHANGED WITH CATHETER D132704. HEART BLOCK WAS SEEN ON THE RECORDING SYSTEM WITH NO AV CONNECTIONS AFTER EXCHANGING THE CATHETER. VENTRICLE PACING WAS DONE AND THE PATIENT WILL UNDERGO BI-VENTRICULAR ICD FOR NEXT DAY. THE PATIENT WAS STABLE. THE CUSTOMER REPORTED THAT THE PHYSICIAN LOOK BACK ON THE RECORD OF THE RECORDING SYSTEM AND SAID THAT THE CATHETER D132705 MAY HAVE BEEN ON THE PATIENT'S BODY WHEN THE HEART BLOCK OCCURRED. MULTIPLE ATTEMPTS WERE DONE TO REQUEST FOR FURTHER DETAILS OF THE EVENT. HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723781 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17024483M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening