BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4082893 · Received September 11, 2014

    Report

    Report Number
    9673241-2014-00346
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 18, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT A CONGENITAL ATRIAL TACHYCARDIA PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER, AND A STUCK DEFLECTION DEVICE MALFUNCTION OCCURRED. HOWEVER, THE CATHETER WAS SUCCESSFULLY REMOVED WITHOUT PATIENT COMPLICATION. THE CATHETER WOULD NOT STRAIGHTEN AND WOULD HOLD ITS DEFLECTION EVEN THOUGH THEY WERE NOT MANEUVERING THE CATHETER TO DEFLECT. THE CATHETER GOT STUCK IN A KINKED MEDTRONIC 8F INPUT INTRODUCER SHEATH (REF: 080011, 11CM) AT THE GROIN. THE PHYSICIAN HAD TO CALL FOR INTERVENTIONAL HELP. THEY WERE ABLE TO GET THE CATHETER AND THE SHEATH OUT WHILE STILL MAINTAINING ACCESS. THE PHYSICIAN THOUGHT THIS COULD HAVE BEEN ATTRIBUTED TO THE CURVE STILL ON THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE PHYSICIAN CUT THE TIP OFF OF THE CATHETER. THEREFORE, THE PRODUCT WILL NOT BE RETURNED. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. THE PHYSICIAN COMMENTED THAT THE CATHETER WAS PARTIALLY DEFLECTED (NOT STRAIGHT) WHEN THERE WAS NO DEFLECTION ON THE HANDLE MECHANISM. HOWEVER, DOES NOT KNOW HOW MUCH DEFLECTION THE CATHETER REFLECTING. THE CATHETER WAS SLIGHTLY DEFLECTED WHEN THERE WAS NO DEFLECTION FROM THE HANDLE. THERE WAS NO RING OR PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. THE EP PHYSICIAN REQUESTED ASSISTANCE FROM AN INTERVENTIONAL PHYSICIAN. THE INTERVENTIONAL PHYSICIAN SCRUBBED IN TO ASSIST. THE INTERVENTIONAL PHYSICIAN FIRST REMOVED THE CATHETER AND THEN HE WAS ABLE TO REMOVE THE SHEATH, WHILE STILL HAVING A WIRE IN. SINCE THEY STILL HAD ACCESS, THEY USED ANOTHER SHEATH AND CONTINUED THE PROCEDURE WITH A NEW CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561894 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17019220M

    Patients

    Seq Age Sex Outcome Treatment
    1