BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7564238 · Received June 4, 2018

    Report

    Report Number
    2029046-2018-01627
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 7, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 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. THEN, THE FORCE SENSOR WAS TESTED AND IT WAS WORKING PROPERLY, THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, ELECTRICAL TEST 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. THEN, THE 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) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. CONCOMITANT PRODUCT: NON-BIOSENSE WEBSTER, INC: AGILITY MED SHEATH MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS/PERICARDIAL DRAIN. WHILE MAPPING THE RIGHT VENTRICLE, THE PATIENT AWOKE FROM ANESTHESIA AND SAT UP. ANESTHESIA WAS OPTIMIZED AND THE PROCEDURE CONTINUED. AFTER 4 ABLATIONS, THE PVCS APPEARED TO BE RESOLVED. PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS YIELDED 110 ML. PERICARDIAL DRAIN WAS LEFT IN PLACE. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WILL BE IN OBSERVATION OVERNIGHT. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT OUTCOME. MEDICAL HISTORY INCLUDES NEPHRECTOMY, CHOLECYSTECTOMY, HYSTERECTOMY, HYPOTHYROIDISM, AND EJECTION FRACTION OF 61%. THERE WERE NO ADDITIONAL PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT MOVEMENT AND SITTING UP DURING MAPPING. THERE WERE NO ISSUES OR ERRORS REPORTED WITH ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING TRANSSEPTAL PUNCTURE. SHEATH WAS AN AGILITY MED (UNSPECIFIED). GENERATOR WAS SET ON POWER CONTROL MODE AT 30 WATTS WITH AN AVERAGE IMPEDANCE OF 132 OHMS, MAXIMUM IMPEDANCE OF 172 OHMS, AND A MAXIMUM IMPEDANCE DROP OF 23 OHMS. THERE IS NO INFORMATION REGARDING OTHER GENERATOR PARAMETERS/SETTINGS, POWER TITRATION, OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. TOTAL ABLATION TIME FOR THE 4 ABLATIONS WAS 1 MINUTE AND 56 SECONDS. IRRIGATED CATHETER FLOW WAS SET AT 8 ML/MIN. THERE IS NO INFORMATION REGARDING ANTICOAGULATION DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE, CATHETER PROXIMITY, OR CATHETER ZEROING. THERE WERE NO ISSUES OR ERRORS REPORTED WITH ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406546 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17767009L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R