BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6490158 · Received April 13, 2017

    Report

    Report Number
    9673241-2017-00274
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    March 16, 2017
    Report Date
    April 4, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON MARCH 11, 2019 STATING THAT THE PATIENT WAS A 66 YEAR OLD FEMALE. LEGACY MANUFACTURER¿S REFERENCE NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ORIGINALLY, THE PRODUCT REPORTED WAS A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER / MODEL #: D-1336-00 / LOT #: UNKNOWN_D-1336-00. ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 4, 2017 PROVIDING A CORRECTED PRODUCT. THE CORRECT PRODUCT IS THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER / MODEL #: D-1327-05-S/LOT #: UNK_D-1327-05-S. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON JUNE 8, 2017. THE PATIENT ALSO SUFFERED POST-PROCEDURE DYSPNEA (REQUIRING NO MEDICAL OR SURGICAL INTERVENTION). THE DYSPNEA ISSUE IS ONGOING. THE PRINCIPAL INVESTIGATOR ASSESSED THE DYSPNEA AS POSSIBLY PROCEDURE-RELATED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING INTERVENTIONS AND PATIENT OUTCOMES ON SEPTEMBER 22, 2017. DURING THE PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA. NO INTERVENTIONS WERE PERFORMED. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 2, THE PATIENT DEVELOPED A URINARY TRACT INFECTION. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS COMPLAINT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND PROBABLY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 2, THE PATIENT DEVELOPED PULMONARY EDEMA. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND PROBABLY INDEX PROCEDURE-RELATED. ON POST-PROCEDURE DAY 1, THE PATIENT DEVELOPED DYSPNEA. NO INTERVENTIONS WERE ADMINISTERED. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, NOT INVESTIGATIONAL DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. (B)(4).

    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 MEDICAL PRODUCTS: CARTO 3 SYSTEM; MODEL #: M-4800-01; SERIAL #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION AS IN THE 3500A INITIAL REPORT THE FOLLOWING STATEMENT WAS ADDED IN ERROR: ¿SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED.¿ MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER AND SUFFERED A HEMATOMA, PULMONARY CONGESTION, AND A URINARY INFECTION. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION AND IF ANY INTERVENTION WAS PERFORMED. NO INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. SINCE THIS ADVERSE EVENT MIGHT RESULT IN 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
    272934 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other