BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8703734 · Received June 17, 2019

    Report

    Report Number
    2029046-2019-03279
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 21, 2019
    Report Date
    May 22, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 4/22/2020, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION WHICH INDICATED THAT NO MEDICATION WAS PROVIDED AS A FORM OF INTERVENTION AND NO OTHER INTERVENTION/TREATMENT WAS REQUIRED. THE EVENT CONTINUES TO BE MDR REPORTABLE BECAUSE EXTENDED HOSPITALIZATION WAS REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 10/7/2020, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION WHICH INDICATES THE OUTCOME OF THE PERICARDIAL EFFUSION HAS BEEN UPDATED FROM RESOLVING TO RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30178188L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. MANUFACTURER¿S REF # (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER INC. (BWI) IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE ON (B)(6) 2019 WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED PERICARDIAL EFFUSION REQUIRING MEDICATION. POST-PROCEDURE, THE PATIENT DEVELOPED PERICARDIAL EFFUSION. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. IN- PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION WAS REQUIRED. ISSUE IS RESOLVING. THE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT AS UNRELATED TO THE STUDY DEVICE (VISITAG SURPOINT EPU), UNRELATED TO THE STUDY CATHETERS, UNRELATED TO THE BWI NON-INVESTIGATIONAL DEVICE AND CAUSAL INDEX PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499259 THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. D134702 30178188L 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R VISITAG SURPOINT EPU| VISITAG SURPOINT EPU