BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6119637 · Received November 22, 2016

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    Report

    Report Number
    9673241-2016-00817
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17553096M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CEREBROVASCULAR ACCIDENT (CVA) REQUIRING TISSUE PLASMINOGEN ACTIVATOR (TPA). WHEN WAKING UP FROM ANESTHESIA, UNILATERAL PARALYSIS WAS OBSERVED. PATIENT WAS REPORTED TO BE IN STABLE CARDIOVASCULAR CONDITION. COMPUTED TOMOGRAPHY (CT) WAS PERFORMED. POST-CT, THE PATIENT RECEIVED TPA, WHICH LED TO SYMPTOM IMPROVEMENT OVER THE NEXT FEW DAYS. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. PATIENT RECEIVED A CARDIAC CATHETERIZATION MID-CASE, PRIOR TO RADIOFREQUENCY ABLATION, IN ORDER TO ASSESS DISTANCE FROM THE CORONARY VESSELS. IT WAS NOTED THAT THE CARDIAC CATHETERIZATION WAS THE LIKELY CAUSE OF THE STROKE. IT WAS ALSO NOTED THAT THE PHYSICIAN WAS NEVER IN THE ARTERIAL CIRCULATION WITH ANY BIOSENSE WEBSTER, INC. PRODUCTS. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. THERE WERE NO ISSUES REPORTED WITH THE CATHETER. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771897 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17553096M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R