BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 7010457 · Received November 8, 2017

    Report

    Report Number
    2029046-2017-01104
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    October 15, 2017
    Report Date
    October 16, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL INFORMATION WAS RECEIVED ON 1/31/2018 AND NOT 2/1/2018. AS SUCH, THE CORRECT ADDITIONAL MFR NARRATIVE INFORMATION STATEMENT IS AS FOLLOWS: "ON 3/31/2018 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS A (B)(6) MALE WHO UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL SF CATHETER. CONCOMITANT PRODUCTS INCLUDED THE FOLLOWING BIOSENSE WEBSTER INC. PRODUCTS: 1. LASSO CATHETER (US CATALOG NUMBER OR LOT NUMBER UNKNOWN) 2. CARTO 3 EP NAVIGATION SYSTEM WITH CARTOFINDER MODULE (VERSION (B)(4)) (US CATALOG OR SERIAL NUMBER UNKNOWN) 3. SMARTABLATE GENERATOR (US CATALOG OR SERIAL NUMBER UNKNOWN). CONCOMITANT PRODUCTS ALSO INCLUDED A NON-BIOSENSE WEBSTER INC. PRODUCT: ST. JUDE MEDICAL AGILIS SHEATH" (B)(4).

    Additional Manufacturer Narrative · 0

    ON 2/1/2018 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS A (B)(6) MALE WHO UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL SF CATHETER. CONCOMITANT PRODUCTS INCLUDED THE FOLLOWING BIOSENSE WEBSTER INC. PRODUCTS: 1. LASSO CATHETER (US CATALOG NUMBER OR LOT NUMBER UNKNOWN) 2. CARTO 3 EP NAVIGATION SYSTEM WITH CARTOFINDER MODULE (VERSION (B)(4)) (US CATALOG OR SERIAL NUMBER UNKNOWN) 3. SMARTABLATE GENERATOR (US CATALOG OR SERIAL NUMBER UNKNOWN) CONCOMITANT PRODUCTS ALSO INCLUDED A NON-BIOSENSE WEBSTER INC. PRODUCT: ST. JUDE MEDICAL AGILIS SHEATH. (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT REQUIRED 2 DAYS OF HOSPITALIZATION.

    Additional Manufacturer Narrative · 0

    ON 12/10/2018 AND ERROR WAS NOTED IN SUPPLEMENTAL MDR # 2 WHICH REQUIRED THIS CORRECTION NOTICE. THE ADDITIONAL INFORMATION WAS RECEIVED ON 1/31/2018 AND NOT 3/31/2018. AS SUCH, THE CORRECT STATEMENT IS AS FOLLOWS: "ON (B)(6) 2018 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS A (B)(6) YEAR OLD MALE WHO UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL SF CATHETER. CONCOMITANT PRODUCTS INCLUDED THE FOLLOWING BIOSENSE WEBSTER INC. PRODUCTS: LASSO CATHETER (US CATALOG NUMBER OR LOT NUMBER UNKNOWN). CARTO 3 EP NAVIGATION SYSTEM WITH CARTOFINDER MODULE (VERSION 6.0) (US CATALOG OR SERIAL NUMBER UNKNOWN). SMARTABLATE GENERATOR (US CATALOG OR SERIAL NUMBER UNKNOWN). CONCOMITANT PRODUCTS ALSO INCLUDED A NON-BIOSENSE WEBSTER INC. PRODUCT: ST. JUDE MEDICAL AGILIS SHEATH". MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    ON 6/15/2018, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE PATIENT DEVELOPED HYPOXIA (REQUIRING INCENTIVE SPIROMETRY) NOT HYPOXEMIA (REQUIRING INCENTIVE SPIROMETRY), AS PREVIOUSLY REPORTED. ON POST-PROCEDURE DAY 2, THE PATIENT DEVELOPED HYPOXIA. INTERVENTIONS INCLUDED INCENTIVE SPIROMETRY. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. MANUFACTURER'S REF # (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. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL SF CATHETER AND SUFFERED PERICARDITIS (REQUIRING CHEST COMPUTED TOMOGRAPHY, PULMONARY ANGIOGRAPHY, CHEST X-RAY, AND MEDICATION), HYPOXEMIA (REQUIRING INCENTIVE SPIROMETRY), ATRIAL FLUTTER (REQUIRING DC CARDIOVERSION), PLEURAL EFFUSION (REQUIRING DRAINAGE OF PLEURAL FLUID), AND CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND MEDICATION). ON POST-PROCEDURE DAY 2, THE PATIENT DEVELOPED PERICARDITIS. INTERVENTIONS INCLUDED CHEST COMPUTED TOMOGRAPHY, PULMONARY ANGIOGRAPHY, CHEST X-RAY, AND AN UNSPECIFIED MEDICATION. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT INVESTIGATIONAL DEVICE RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 2, THE PATIENT DEVELOPED HYPOXEMIA. INTERVENTIONS INCLUDED INCENTIVE SPIROMETRY. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 10, THE PATIENT DEVELOPED ATYPICAL LEFT ATRIAL FLUTTER. INTERVENTIONS INCLUDED DC CARDIOVERSION. ISSUE IS ONGOING AND UNCHANGED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 14, THE PATIENT DEVELOPED A PLEURAL EFFUSION. INTERVENTIONS INCLUDED DRAINAGE OF PLEURAL FLUID. ISSUE IS ONGOING AND UNCHANGED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, SERIOUS, NOT INVESTIGATIONAL DEVICE RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 14, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. INTERVENTIONS INCLUDED A PERICARDIOCENTESIS AND AN UNSPECIFIED MEDICATION. ISSUE IS ONGOING AND IMPROVED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. RADIOFREQUENCY WAS DELIVERED VIA 278 APPLICATIONS. THERE WERE NO DEVICE DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788697 THERMOCOOL SMARTTOUCH SIMILAR DEVICE D132702, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 17667194L

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R