BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 6753706 · Received July 31, 2017

    Report

    Report Number
    9673241-2017-00607
    Event Type
    Injury
    Date Received
    July 31, 2017
    Date of Event
    July 7, 2017
    Report Date
    July 9, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835003130
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALSO NOTED THAT HEPARIN AND DABIGATRAN WERE REVERSED AFTER THE EFFUSION. THERE WERE NO ERRORS REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO 3 EXTERNAL REFERENCE PATCH (MODEL# D-1283-02 LOT# LL013454). WEBSTER CS 10 POLE (MODEL#D-1317-07-S LOT# 17596626M). COOK MEDICAL TRANSSEPTAL NEEDLE (REFG02364/7524323). ST. JUDE MEDICAL SL0 8 FRENCH SHEATH (REF407449/5881841). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A REDO PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE UNDER GENERAL ANESTHESIA FOR ATRIAL FIBRILLATION AND ATRIAL ECTOPY WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A PERICARDIAL EFFUSION REQUIRING EXTENDED HOSPITALIZATION. CORONARY SINUS (CS) CATHETER WAS PLACED IN THE CS, TRANSSEPTAL PUNCTURE WAS PERFORMED, AND THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER WAS POSITIONED IN THE RIGHT ATRIUM FOR MAPPING. A X-RAY REVEALED CONTRAST MEDIUM IN THE PERICARDIAL SPACE. PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT REMAINED IN THE CATHETERIZATION LAB UNDER GENERAL ANESTHESIA WHILE THE PHYSICIAN EVALUATED THE SEVERITY OF THE EFFUSION/PERFORATION. AFTER APPROXIMATELY 45-60 MINUTES, THE PATIENT EMERGED FROM ANESTHESIA AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING. PATIENT WAS UNDER GENERAL ANESTHESIA FOR 90 MINUTES. PATIENT REQUIRED ONE DAY OF EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR MONITORING. PATIENT HAS SINCE FULLY RECOVERED. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE A NARROW ANATOMICAL WINDOW FOR TRANSSEPTAL PUNCTURE. IT WAS NOTED THAT THE EVENT OCCURRED DURING TRANSSEPTAL PHASE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PROCEDURE OR PATIENT CONDITION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A COOK MEDICAL TRANSSEPTAL NEEDLE. SHEATH IN USE WAS A ST. JUDE MEDICAL SL0 8 FRENCH SHEATH. GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WERE NOT REPORTED, AS NO ABLATION WAS PERFORMED. PATIENT RECEIVED ANTICOAGULANT (HEPARIN 8000 UNITS) DURING THE PROCEDURE. NO ACTIVATED CLOTTING TIME WAS REPORTED. IT WAS NOTED THAT ORAL DABIGATRAN WAS TAKEN PRE-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535416 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-06-S 17660960L 10846835003130

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization