BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF UNI-DIRECTIONAL CATHETER

    MDR report key: 8095843 · Received November 21, 2018

    Report

    Report Number
    2029046-2018-02315
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    October 23, 2018
    Report Date
    October 23, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009330
    PMA / PMN Number
    P030031/S034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON NOVEMBER 27, 2018. THEREFORE, POPULATED DEVICE AVAILABLE FOR EVALUATION?, IS DEVICE RETURNED TO MANUFACTURER? AND DATE DEVICE RETURNED TO MANUFACTURER. THE PRODUCT WAS VISUALLY INSPECTED AND APPEARS TO BE IN NORMAL CONDITION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS NOTED ON NOVEMBER 21, 2018 THAT FOLLOW UP TYPE: IS HOSPITALIZATION INITIAL/PROLONGED WAS NOT SELECTED IN THE INITIAL REPORT, HOWEVER, EXTENDED HOSPITALIZATION WAS REQUIRED, THEREFORE, THIS FIELD HAS BEEN UPDATED ACCORDINGLY. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 57-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SF UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, MEDICATION AND BLOOD TRANSFUSION. DURING THE PROCEDURE, WHILE ABLATION WAS PERFORMED TOWARDS THE ANNULUS, A STEAM POP WAS HEARD. THE POWER WAS AT 35 WATTS AND SMART ABLATE WAS RUNNING AT 15 ML/MIN AS PER RECOMMENDATIONS. AT THE END OF THE PROCEDURE DURING THE CAVOTRICUSPID ISHMUS (CTI) LINE ABLATION, CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. 1 UNIT OF BLOOD AND 1 UNIT OF FRESH FROZEN PLASMA (FFP) WERE ADMINISTERED. MEDICATION (INOTROPES) WAS ALSO ADMINISTERED. THE PROCEDURE DELAYED FOR 30 MINUTES. THREE DAYS OF EXTENDED HOSPITALIZATION WERE REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD CONDITIONS. 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 INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER'S REFERENCE #(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 30063588L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: BIOSENSE WEBSTER, INC. PRODUCT - SMARTABLATE GENERATOR: CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SF UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, MEDICATION AND BLOOD TRANSFUSION. DURING THE PROCEDURE, WHILE ABLATION WAS PERFORMED TOWARDS THE ANNULUS, A STEAM POP WAS HEARD. THE POWER WAS AT 35WATTS AND SMART ABLATE WAS RUNNING AT 15ML/MIN AS PER RECOMMENDATIONS. AT THE END OF THE PROCEDURE DURING THE CTI LINE ABLATION, CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. 1 UNIT OF BLOOD AND 1 UNIT OF FRESH FROZEN PLASMA (FFP) WERE ADMINISTERED. MEDICATION (INOTROPES) WAS ALSO ADMINISTERED. THE PROCEDURE DELAYED FOR 30 MINUTES. THREE DAYS OF EXTENDED HOSPITALIZATION WERE REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN THOUGHT THE ADVERSE EVENT COULD HAVE BEEN RELATED TO PATIENT¿S ANATOMY OR TO THE BIOSENSE WEBSTER, INC. CATHETER; HOWEVER; HE WASN¿T SURE. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE GENERATOR PARAMETERS INCLUDED POWER CONTROL MODE AT 35 WATTS AND A 999 SECONDS CUT-OFF. THE POWER DID NOT TITRATE DURING THE ABLATION. THE OVERALL TIME FOR ABLATION WAS APPROXIMATELY 5 MINUTES. THE LAST ABLATION CYCLE TIME WAS APPROXIMATELY 1 MINUTE. THE CATHETER IRRIGATION WAS SET AT 15ML/MIN. THE PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE WHICH WAS REVERTED WHEN THE TAMPONADE OCCURRED. 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. THE STEAM POP ISSUE WAS ASSESSED AS NOT REPORTABLE. STEAM POP IS A NORMAL PHYSIOLOGICAL REACTION OF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934623 THERMOCOOL® SF UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30063588L 10846835009330

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R