BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3115569 · Received May 16, 2013

    Report

    Report Number
    9673241-2013-00157
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL #:M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: MODEL #:M-5463-01, SERIAL #: (B)(4). COOLFLOW PUMP: MODEL #:M-5491-02, SERIAL #: UNKNOWN, SOUNDSTAR CATHETER: MODEL #:M-5723-05, LOT #: UNKNOWN_M-5723-05. LASSO NAVIGATIONAL VARIABLE ECO CATHETER: MODEL #: D-1343-00, LOT #: UNKNOWN_D-1343-00. MANUFACTURER'S REF. NO: PI1-DCJJQH

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON (B)(4) 2013. THREE WEEKS LATER THE PATIENT WAS PRESENTED IN THE ER WITH FEBRILE, MALAISE AND CHEST DISCOMFORT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PATIENT WAS ESOPHAGEAL PERFORATION THREE WEEKS POST ABLATION WITH NO PROCEDURAL PROBLEMS. THERE WERE NO OTHER FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE PERFORATION. THE PHYSICIAN DID NOT HAVE ANY ISSUES MANIPULATING THE CATHETER. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL SIGNALS. THE RF GENERATOR WAS SET TO POWER CONTROL MODE AT 25 ¿ 40 WATTS. THE TEMPERATURE CUT-OFF SETTING WAS SET TO 65 WATTS AND THE FLOW SETTING WAS SET TO 8CC TO 15CC. ACT WAS AT 267, 307, 319 AND 214. ADDITIONAL CONCOMITANT PRODUCT: BWI - PREFACE SHEATH: MODEL #: UNKNOWN, LOT #: UNKNOWN. PER THE ADDITIONAL INFORMATION RECEIVED UPDATED THE PRODUCT: FROM: TCOOL SF CARTO 3 UNI, TC, J. MODEL #: D-1315-04-S. LOT #: UNKNOWN_D-1315-04-S TO: THERMOCOOL SF CARTO 3,F-J,TC, MODEL #: D-1313-04-S, LOT #: UNKNOWN_D-1313-04-S. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON THE PATIENT STATUS ON (B)(4) 2013. THE BWI FIELD REPRESENTATIVE STATED THAT THE LAST UPDATE THAT HE RECEIVED WAS A COUPLE OF WEEKS AGO DURING WHICH THE PATIENTS STATUS WAS OKAY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BWI FIELD REPRESENTATIVE DISCOVERED ON (B)(6) 2013 THAT A PATIENT HAD AN ATRIAL-ESOPHAGEAL FISTULA THAT NEEDED SURGICAL INTERVENTION FOLLOWING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE PERFORMED APPROXIMATELY TWO WEEKS AGO. THE BWI FIELD REPRESENTATIVE HAS NO OTHER INFORMATION ABOUT THE CAUSE OF THE ISSUE OR THE PATIENT CONDITION. INFORMATION ON THE EVENT WAS REQUESTED FROM THE BWI FIELD REPRESENTATIVE, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216686 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-04-S UNKNOWN_D-1315-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R