BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3913345 · Received July 3, 2014

    Report

    Report Number
    9673241-2014-00245
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. CONCOMITANT BWI PRODUCTS: PRODUCT: STOCKERT 70 RF GENERATOR; US CATALOG # S7001; SERIAL # (B)(6). PRODUCT: COOLFLOW IRRIGATION PUMP; US CATALOG # CFP002; SERIAL # (B)(6). PRODUCT: CARTO 3 SYSTEM; US CATALOG # FG540000; SERIAL # (B)(4). PRODUCT: WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID; US CATALOG # BD710DF282CT; LOT # 16103171M. A NOTIFICATION HAS BEEN SENT TO THE MANUFACTURER OF THE COMPETITOR'S PRODUCT INVOLVED IN THIS EVENT (ST. JUDE MEDICAL / PRODUCT: SAFL SHEATH). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT PROCEDURE WITH A NAVI-STAR THERMO-COOL ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC PERFORATION. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THERE WAS NO MEDICAL INTERVENTION ADMINISTERED. THE PATIENT REQUIRE HOSPITALIZATION AND WAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE RELATED. SETTINGS DURING THE EVENT INCLUDE: GENERATOR WAS USED UNDER POWER CONTROL MODE, POWER SETTING AT 30 WATTS, IRRIGATION SETTING AT 17 ML/MIN. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389465 NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S UNKNOWN_D-1197-17-S_JUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L