BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 7541920 · Received May 24, 2018

    Report

    Report Number
    2029046-2018-01588
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    April 27, 2018
    Report Date
    April 29, 2018
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835009163
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/14/2018, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS A MALE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR OBSERVATION. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT. ADDITIONALLY, PRODUCT DETAILS WERE PROVIDED, AS SUCH THE FOLLOWING CORRECTIONS ARE BEING PROCESSED IN RESPECTIVE FIELDS: BRAND NAME UPDATED FROM THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER TO THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. COMMON DEVICE NAME UPDATED FROM SIMILAR DEVICE D132701, PMA # P030031/S053 TO CARDIAC ABLATION PERCUTANEOUS CATHETER. CATALOG # UPDATED FORM D132700 TO D133602. LOT # UPDATED FROM UNKNOWN TO 17755132M. UDI # UPDATED FROM (B)(4) TO (B)(4). MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. NO: (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER MAPPING AND SOME ABLATION IN THE LEFT ATRIUM, A TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384292 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 17755132M 10846835009163

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R