BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4361133 · Received December 24, 2014

    Report

    Report Number
    9673241-2014-00618
    Event Type
    Injury
    Date Received
    December 24, 2014
    Date of Event
    December 1, 2014
    Report Date
    December 2, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY REPORT (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER CONCOMITANT MEDICAL PRODUCTS: CARTO 3 SYSTEM: SER# (B)(4), SMART ABLATE GENERATOR: SER# (B)(4), SMART ABLATE PUMP: SER# (B)(4), SMART ABLATE REMOTE: SER# (B)(4), SMART TOUCH CATHETER: CAT# D132705, LOT# UNKNOWN, QUADRAPOLAR CATHETER: CAT# F6QF005CT, LOT# UNKNOWN. (B)(4). SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT, (B)(6), UNDERWENT AN ISCHEMIC VT PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. A PERICARDIOCENTESIS WAS PERFORMED AND 400 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND WAS OBSERVED OVERNIGHT IN THE CRITICAL CARE UNIT. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. THERE IS NO CLAIM OF DEVICE MALFUNCTION. THIS ADVERSE EVENT IS CONSIDERED TO BE SERIOUS AND MDR REPORTABLE. THE COMPLAINT DEVICE HAS BEEN DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849440 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R