BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, ELECTRODE RECORDING

    MDR report key: 4145325 · Received October 6, 2014

    Report

    Report Number
    2029046-2014-00358
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    June 1, 2006
    Report Date
    September 9, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE,L NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, DEVICE MALFUNCTION CANNOT BE CONFIRMED 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCT: PRODUCT NAME: LASSO: US CATALOG #: UNKNOWN, LOT #: UNKNOWN. PRODUCT NAME: ACUNAV 10FR: US CATALOG #: UNKNOWN, LOT #: UNKNOWN. NON-BWI PRODUCT WAS ALSO USED: PRODUCT NAME: 4-MM INTERNAL COOLED-TIP CATHETER (EP TECHNOLOGIES): CATALOG AND LOT #: UNKNOWN. MANUFACTURER'S REFERENCE # (B)(4), ARE RELATED TO THE SAME EVENT. (B)(4).

    Description of Event or Problem · 1

    THE PURPOSE OF THIS PROSPECTIVE MULTICENTER STUDY WAS TO COMPARE RESULTS OF CATHETER ABLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (PAF) AND THOSE WITH NONPAROXYSMAL ATRIAL FIBRILLATION (NPAF). PATIENTS WERE ENROLLED AS FOLLOWS: 953 PATIENTS FROM CLEVELAND CLINIC (CLEVELAND, OH, USA) FROM DECEMBER 2000 TO JUNE 2004; 102 PATIENTS FROM SUTTER PACIFIC HEART CENTER (SAN FRANCISCO, CA, USA) FROM JUNE 2001 TO DECEMBER 2002; 89 PATIENTS FROM SOUTHLAKE REGIONAL HEALTH CENTER (NEWMARKET, ONTARIO, CANADA) FROM MARCH 2004 TO MARCH 2006; AND 260 PATIENTS FROM UMBERTO I HOSPITAL (MESTRE-VENICE, ITALY) FROM SEPTEMBER 2002 TO JUNE 2006. FROM THE REPORT: - 5 PATIENTS HAD TAMPONADE, - 6 PATIENTS HAD THROMBOEMBOLIC EVENTS INCLUDING TRANSIENT ISCHEMIC ATTACK OR STROKE, - 184 PATIENTS HAD PV STENOSIS ( OF THOSE 18 PATIENTS HAD SEVERE PULMONARY VEIN STENOSIS; 44 PATIENTS (3.1%) HAD MODERATE (51%¿70%) PV STENOSIS; ANOTHER 122 HAD MILD (31%¿50%) STENOSIS. - 1 PATIENT HAD A NONHEMORRHAGIC STROKE AND UNDERWENT AN ANGIOPLASTY. HE SUBSEQUENTLY HAD HEMORRHAGIC CONVERSION REQUIRING HEMICRANIECTOMY. HE LATER DEVELOPED ACUTE DEEP VENOUS THROMBOSIS, WHICH WAS FOLLOWED 2 WEEKS LATER BY A FATAL PULMONARY EMBOLISM (THIS EVENT IS REPORTED UNDER RELATED COMPLAINT.) - 5 PATIENTS HAD PARTIAL OR COMPLETE DIAPHRAGMATIC PARALYSIS. - 2 PATIENTS HAD TRANSIENT ALTERED MENTAL STATUS. - 1 PATIENT HAD OPTIC NEURITIS. - 3 PATIENTS HAD MAJOR VASCULAR BLEED. - 1 PATIENT HAD RETROPERITONEAL BLEEDING. - 1 PATIENT HAD HEMOTHORAX. - 1 PATIENT HAD DEEP VENOUS THROMBOSIS. - 1 PATIENT HAD FEMORAL ARTERIOVENOUS FISTULA. - 1 PATIENT HAD CORONARY EMBOLISM. -1 PATIENT HAD LASSO ENTRAPMENT IN THE MITRAL VALVE (THIS EVENT IS REPORTED UNDER RELATED COMPLAINT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622513 CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) LASSO UNKNOWN_LASSO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR