BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 7866012 · Received September 11, 2018

    Report

    Report Number
    2029046-2018-02046
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    August 14, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835003376
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 65-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVC) WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE BIOSENSE WESTER INC. (BWI) FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2018. SINCE THE PRODUCT WAS RECEIVED, POPULATED, DEVICE AVAILABLE FOR EVALUATION, IS DEVICE RETURNED TO MANUFACTURER? AND DATE DEVICE RETURNED TO MANUFACTURER. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. ELECTRICAL TESTING WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. IRRIGATION AND DEFLECTION TEST WERE PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. 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. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATE THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER REF NO: (B)(4).

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17367207M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCT: 1. NON-BIOSENSE WEBSTER INC. PRODUCT - ST. JUDE MEDICAL SHORT GROIN ACCESS SHEATH 8.5 FR 2. CARTO® 3 U.S. CATALOG#: UNKNOWN SERIAL NUMBER: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVC) WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE, THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPH (ICE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 200 CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT OVERNIGHT AND THEN REQUIRED 2 EXTRA DAYS OF HOSPITALIZATION IN THE REGULAR NURSING FLOOR. PATIENT¿S OUTCOME IS FULLY RECOVERED. PATIENT¿S ANATOMY WAS CITED AS A FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. A ST. JUDE MEDICAL SHORT GROIN ACCESS SHEATH 8.5 FR WAS USED. THE GENERATOR PARAMETERS INCLUDED POWER CONTROL MODE WITH A MAXIMUM POWER OF 50 WATTS AND A TEMPERATURE CUT-OFF VALUE OF 50 DEGREES CELSIUS. THE EXACT TIME OF INJURY IS UNKNOWN; HOWEVER, THEY WERE USING THE POWER AROUND 25 WATTS, THE TEMPERATURE WAS AT 40 DEGREES CELSIUS AND THE IMPEDANCE WAS AT 120 OHMS. THE POWER WAS TITRATED DURING THE ABLATION AND IT REACHED ITS TARGET SETTING ON 10-20 SECONDS. THE CATHETER IRRIGATION WAS SET AT 17 CC/MIN FOR 30 WATTS AND BELOW AND 30 CC/MIN FOR 31 WATTS AND HIGHER. THE PATIENT RECEIVED ANTICOAGULANT (UNSPECIFIED) DURING THE PROCEDURE WITH AN ACTIVATED CLOTTING TIME (ACT) OF 250-300 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707164 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC 17367207M 10846835003376

    Patients

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