BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 6888396 · Received September 22, 2017

    Report

    Report Number
    9673241-2017-01091
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    August 29, 2017
    Report Date
    August 29, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031
    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. CONCOMITANT PRODUCTS: LASSO NAV, U.S. CATALOG #: D134901, LOT #: UNKNOWN. SOUNDSTAR, U.S. CATALOG #: 10439011, LOT #: UNKNOWN. NON BIOSENSE WEBSTER, INC. - JLL CORONARY SINUS: BEEAT CATHETER. NON BIOSENSE WEBSTER, INC. - JLL EP STAR HIS RV CATHETER. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL LIBERO. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SL0 8.5 FRENCH LONG SHEATH X 2. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL AGILIS 8.5 FRENCH SHEATH. NON BIOSENSE WEBSTER, INC. - ESOPHASTAR ESOPHAGEAL THERMOMETER. NON BIOSENSE WEBSTER, INC. - JLL TRANSSEPTAL NEEDLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-ABLATION PHASE, THE HIS CATHETER WAS REMOVED FROM THE RIGHT VENTRICLE. SUBSEQUENTLY, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS CONFIRMED VIA TRANSTHORACIC ECHOCARDIOGRAM (TTE). PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF VENOUS BLOOD. PATIENT¿S LEVEL OF CONSCIOUSNESS WAS WITHIN NORMAL LIMITS. PATIENT WILL BE MONITORED IN THE INTENSIVE CARE UNIT. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. PHYSICIAN INDICATED THAT PRESUMABLY THE HIS RV CATHETER MOVED SIGNIFICANTLY SECONDARY TO RESPIRATORY AND CARDIOVASCULAR PULSATIONS. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A JLL TRANSSEPTAL NEEDLE. SHEATHS USED INCLUDED ST. JUDE MEDICAL SL0 8.5 FRENCH LONG SHEATH X 2 AND A ST. JUDE MEDICAL AGILIS 8.5 FRENCH SHEATH. GENERATOR WAS SET ON POWER CONTROL MODE. THERE IS NO FURTHER INFORMATION REGARDING GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, LAST ABLATION CYCLE TIME AT THE SITE OF INJURY, IRRIGATED CATHETER FLOW SETTING, OR ANTICOAGULATION DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE, CATHETER PROXIMITY, OR CATHETER ZEROING. THERE WERE NO ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. 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
    667657 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R