BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER DUO-DECAPOLAR CATHETER

    MDR report key: 1801893 · Received August 16, 2010

    Report

    Report Number
    2029046-2010-00043
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER PASSED ALL ELECTRICAL AND DEFLECTION TESTS. ADDITIONAL TESTING WAS CONDUCTED TO EVALUATE THE INTEGRITY OF THE CATHETER'S TIP STIFFNESS. RESULTS OF THE ADDITIONAL TEST INDICATED THAT THE CATHETER PASSED BUCKLE FORCE TEST, TIP STIFFNESS TEST AND SIDE FORCE TEST. THE CATHETER PERFORMED AS DESIGNED AND ANY TIP STIFFNESS ISSUE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: M-4800-01, (B)(4). STOCKERT RF GENERATOR: MODEL #: M-5463-01, (B)(4). NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER: MODEL #: D-1197-17-S, LOT #: 15122869. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION OF INAPPROPRIATE SINUS TACHYCARDIA, A LEFT ATRIAL PERFORATION OCCURRED. THIS RESULTED IN CARDIAC TAMPONADE. CARDIO THORACIC SURGEONS SUTURED THE PERFORATION. HE BELIEVES THAT THE DUO-DECAPOLAR CATHETER WENT THROUGH THE PFO (PATENT FORAMEN OVALE) AND PERFORATED THE LEFT ATRIAL DOME. THE PERFORATION WAS NOT AT THE SITE OF THE ABLATION. THE PHYSICIAN FELT THAT THIS CATHETER IS TOO STIFF, HOWEVER, HE DOES NOT BELIEVE THIS EVENT WAS RELATED TO ANY BWI EQUIPMENT. THE HOSPITAL HAS DECLINED TO PROVIDE FURTHER INFORMATION ON DETAILED INFORMATION AND THE PATIENT'S UPDATED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEBSTER DUO-DECAPOLAR CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1171-35-S UNKNOWN_D-1171-35-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R