BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH BIDIRECTIONAL

    MDR report key: 7957908 · Received October 11, 2018

    Report

    Report Number
    2029046-2018-02160
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    September 8, 2017
    Report Date
    September 20, 2018
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 10/17/2018, ADDITIONAL EVENT INFORMATION WAS RECEIVED INDICATING THE HEMATOMA DEVELOPED IN THE RIGHT GROIN AND THE SITE CONFIRMED THERE WERE 3 X SIZE 7 SHEATHS IN THAT VEIN. IT IS UNKNOWN IF A BWI SHEATH WAS USED DURING THE PROCEDURE. SITE DOESN¿T HAVE THE LOT NUMBERS OF THOSE SHEATHS. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 3/19/2019, ADDITIONAL INFORMATION RELATED TO THE REPORTABLE ADVERSE EVENT OF ¿HEMATOMA¿ WAS RECEIVED INDICATING THE PRINCIPLE INVESTIGATOR HAS REASSESSED THE RELATIONSHIP OF THE EVENT AS ¿NOT RELATED¿ TO THE INVESTIGATION DEVICE WHICH WAS PREVIOUSLY ASSESSED AS POSSIBLY RELATED TO INVESTIGATIONAL DEVICE. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED HEMATOMAS X 2 (REQUIRING NO MEDICAL OR SURGICAL INTERVENTIONS). PRE-PROCEDURE, AFTER INTRAVENOUS CANNULATION OF THE RIGHT HAND, THE PATIENT DEVELOPED A HEMATOMA. THERE WERE NO INTERVENTIONS. 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 0, THE PATIENT DEVELOPED A HEMATOMA (LOCATION UNSPECIFIED). THERE WERE NO INTERVENTIONS. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, POSSIBLY DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE PATIENT EVENT. THE ISSUE DID NOT RESULT IN A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION. IT DID NOT LEAD TO A SERIOUS DETERIORATION IN HEALTH OF THE SUBJECT THAT RESULTED IN A LIFE-THREATENING ILLNESS OR INJURY. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE; HOWEVER, BIOSENSE WEBSTER INC. BECAME AWARE OF ADDITIONAL INFORMATION ON 9/20/2018 INDICATING THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. AS SUCH, WE HAVE REASSESSED THE EVENT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799310 SMART TOUCH BIDIRECTIONAL SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O