BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3954196 · Received July 24, 2014

    Report

    Report Number
    2029046-2014-00207
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 2, 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
    PO
    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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCT: CARTO 3 SYSTEM; MODEL #: UNKNOWN; SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, MALE, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN EP-SHUTTLE RF GENERATOR SYSTEM ¿ 100W, SUFFERED AN ESOPHAGEAL FISTULA, WHICH REQUIRED A CARDIAC/GASTRO SURGERY INTERVENTION. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THIS PATIENT HAD AN ATRIAL FIBRILLATION (AFIB) PROCEDURE ON (B)(6) 2014 AND ON (B)(6) 2014 WAS HOSPITALIZED WITH SYMPTOMS ASSOCIATED WITH AN ATRIO-ESOPHAGEAL FISTULA WHICH STARTED ON (B)(6) 2014. THE ATRIO-ESOPHAGEAL FISTULA WAS CONFIRMED WHILE PERFORMING THE CORRECTIVE SURGERY. THE PROGNOSIS WAS RESERVED; HOWEVER, IT WAS STATED THAT THERE WERE POSITIVE SIGNALS OF RECOVERY. THE PATIENT REQUIRED HOSPITALIZATION. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENTS STATUS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE RELATED. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433018 NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1266-01-S UNKNOWN_D-1266-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R