BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHILLI II ABLATION CATHETER

    MDR report key: 2011618 · Received March 9, 2011

    Report

    Report Number
    3001236349-2011-00012
    Event Type
    Injury
    Date Received
    March 9, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    P980003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MDR ID 3001236349-2011-00012: CORRECTED TO : ONE PATIENT WAS RESUSCITATED FROM A PULSELESS ELECTRICAL ACTIVITY ARREST WITHIN 24 HOURS OF THE ABLATION. FROM: TWO PATIENTS REQUIRED PROLONGED VENTILATORY DEPENDENCE SECONDARY TO EXACERBATION OF HEART FAILURE SUPERIMPOSED ON CHRONIC PULMONARY DISEASE.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED IN AN ARTICLE: ONE PATIENT WAS RESUSCITATED FROM A PULSELESS ELECTRICAL ACTIVITY ARREST WITHIN 24 HOURS OF THE ABLATION. THE ARTICLE INDICATES THE FOLLOWING: RF ENERGY (50 W MAXIMUM) WAS DELIVERED VIA AN 8-FR 3.5-MM-TIP OPEN-IRRIGATION CATHETER (THERMOCOOL, BIOSENSE WEBSTER, (B)(4)) OR 8-FR 4-MM-TIP CLOSED-IRRIGATION CATHETER (CHILLI II, BOSTON SCIENTIFIC, (B)(4)). THE ARTICLE DOES NOT INDICATE WHICH CATHETER WAS USED IN THE PATIENTS WITH COMPLICATION

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED IN AN ARTICLE: TWO PATIENTS REQUIRED PROLONGED VENTILATORY DEPENDENCE SECONDARY TO EXACERBATION OF HEART FAILURE SUPERIMPOSED ON CHRONIC PULMONARY DISEASE. THE ARTICLE INDICATES THE FOLLOWING: RF ENERGY (50 W MAXIMUM) WAS DELIVERED VIA AN 8-FR 3.5-MM-TIP OPEN-IRRIGATION CATHETER (THERMOCOOL, BIOSENSE WEBSTER, (B)(4)) OR 8-FR 4-MM-TIP CLOSED-IRRIGATION CATHETER (CHILLI II, BOSTON SCIENTIFIC, (B)(4)). THE ARTICLE DOES NOT INDICATE WHICH CATHETER WAS USED IN THE PATIENTS WITH COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILLI II ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - SAN JOSE UNK78 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O CHILLI II MDR ID 3001236349-2011-00010| CHILLI II MDR ID3001236349-2011-00013