BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3070948 · Received April 22, 2013

    Report

    Report Number
    9673241-2013-00121
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 11, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOUNDSTAR CATHETER, MODEL #: M-5723-05, LOT #: S1081889. MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THE BLOOD PRESSURE STARTED TO DROP (68/43) AFTER ABLATION AT THE RPV WALL FROM POSTERIOR TO ANTERIOR. ABLATION WAS CONTINUED WHILE THE BLOOD PRESSURE WAS MAINTAINED BY MEDICATION. HOWEVER, MORE EFFUSION WAS CONFIRMED DURING ABLATION. 20MM OF EFFUSION WAS CONFIRMED. THE PHYSICIAN DID NOT EXPECT THE AMOUNT OF EFFUSION BECAUSE ACCORDING TO ULTRASOUND FINDINGS ONLY 4.4MM OF EFFUSION WAS INDICATED. THE PHYSICIAN INTERRUPTED ABLATION AND DRAINAGE WAS PERFORMED IMMEDIATELY. THE PATIENT WAS UNDER OBSERVATION IN THE CATHETER LABORATORY. THE PHYSICIAN RESTARTED ABLATION BASED ON THE PATIENT'S CONDITION. PVI AND CTI WERE COMPLETED WITHOUT FURTHER ISSUES. THE PHYSICIAN STATED THAT HE HAD FELT SOME DIFFICULTY WHEN INSERTING THE CS CATHETER (NON BWI PRODUCT) AND THE CARDIAC WALL MIGHT HAVE BEEN DAMAGED BY THE CS CATHETER AT THAT TIME. DUE TO THAT SITUATION, HE ALSO STATED THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE EFFUSION AND J AND J'S PRODUCTS. ADDITIONAL INFORMATION PROVIDED STATED THE EFFUSION WAS CONFIRMED SOON AFTER THE START OF THE PROCEDURE. IT WAS UPDATED THE PATIENT WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171989 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15786553M

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R