BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 6883357 · Received September 21, 2017

    Report

    Report Number
    9673241-2017-01087
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 1, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/3/2017, BIOSENSE WEBSTER RECEIVED CLARIFICATION REGARDING THE MODEL AND LOT/SERIAL NUMBERS OF THE CONCOMITANT BWI PRODUCTS: CONCOMITANT PRODUCTS: C3 CS REFSTAR DEFLECTABLE CATHETER, MODEL # D-1285-01-S, LOT NUMBER UNKNOWN. LASSO NAV ECO CATHETER, MODEL # D-1349-03-S, LOT # 17650293L. NON-NAV LASSO CATHETER, MODEL # D-1220-39-S, LOT # 17677890L. SOUNDSTAR ECO CATHETER, MODEL # M-5723-18, S/N: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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: DECANAV CATHETER, MODEL AND LOT NUMBERS UNKNOWN; LASSO ECO CATHETER, MODEL AND LOT NUMBERS UNKNOWN; NON-NAV LASSO CATHETER, MODEL AND LOT NUMBERS UNKNOWN; SOUNDSTAR ECO CATHETER, MODEL AND LOT NUMBERS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI)/CAVOTRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION/ATRIAL FLUTTER WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A PERICARDIAL EFFUSION REQUIRING PHARMACOLOGIC SUPPORT. UPON ENTERING THE PROCEDURE ROOM, THE PATIENT WAS IN ATRIAL TACHYCARDIA. AFTER THE CS (CORONARY SINUS) CATHETER AND HIS CATHETER WERE PLACED, TRANSSEPTAL PUNCTURE WAS PERFORMED. LAT (LOCAL ACTIVATION TIME) MAP WAS CREATED USING THE DECANAV CATHETER, WHICH INDICATED ATRIAL FLUTTER. CTI WAS ABLATED USING THE SMARTTOUCH SF CATHETER AND THE ATRIAL FLUTTER WAS TERMINATED. LASSO ECO CATHETER AND NON-NAV LASSO CATHETER WERE PLACED IN THE LEFT ATRIUM. LEFT PVI WAS PERFORMED USING THE SMARTTOUCH SF CATHETER. AT THIS POINT, THE PATIENT BECAME HYPOTENSIVE WITH A SYSTOLIC BLOOD PRESSURE OF 90 MMHG. A SMALL PERICARDIAL EFFUSION WAS DETECTED VIA SOUNDSTAR CATHETER. AN UNSPECIFIED MEDICATION WAS ADMINISTERED AND THE BLOOD PRESSURE IMPROVED. NO PERICARDIOCENTESIS WAS PERFORMED. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT OUTCOME IS IMPROVED. IT WAS NOTED THAT THE ADVERSE EVENT MAY HAVE OCCURRED DURING ABLATION PHASE. THERE WERE NO 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 PROCEDURE AND PATIENT CONDITION. PHYSICIAN INDICATED THAT PLACEMENT OF THE SMARTTOUCH SF CATHETER IN THE LEFT ATRIAL APPENDAGE (LAA) FELT A BIT UNUSUAL. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNSPECIFIED NEEDLE. THERE IS NO SHEATH INFORMATION. GENERATOR WAS SET ON POWER CONTROL MODE. THERE IS NO 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 WERE NO ERRORS REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661914 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 17669576L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention