BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSIUS? THERMO-COOL? ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3961285 · Received July 28, 2014

    Report

    Report Number
    2029046-2014-00215
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 REPORT (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCT: 1.STOCKERT 70 SYSTEM, MFG #: M-5463-01, SERIAL #:(B)(4). 2.COOLFLOW PUMP: MODEL #:UNKNOWN, SERIAL#:UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A CELSIUS THERMOCOOL CATHETER, SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED A PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED DURING THE NON-CARTO SYSTEM PROCEDURE. FLUOROSCOPY CONFIRMED A PERICARDIAL EFFUSION. THE PHYSICIAN BELIEVED THAT IT WAS CAUSED BY A PERFORATION ON THE RIGHT VENTRICULAR OUTFLOW TRACT - (RVOT) WHERE HE WAS MAPPING AT THE TIME. A PERICARDIOCENTESIS WAS PERFORMED AND 500 CC OF FLUID WERE REMOVED. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438047 CELSIUS? THERMO-COOL? ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1189-03-S UNKNOWN_D-1189-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R