BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECANAV ELECTROPHYSIOLOGY CATHETER

    MDR report key: 18260808 · Received December 4, 2023

    Report

    Report Number
    2029046-2023-02817
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 6, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835008807
    PMA / PMN Number
    K080425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4). HAS TWO REPORTS: (1) MFR # 2029046-2023-02816 FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER). (2) MFR FOR PRODUCT CODE R7F282CT (DECANAV ELECTROPHYSIOLOGY CATHETER).

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 13-DEC-2023. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A DECANAV ELECTROPHYSIOLOGY CATHETER. IT WAS REPORTED THAT AFTER RECEIVING THE SHIPMENT OF NEW PRODUCTS, TWO OF THE BOXES WERE COMPLETELY BROKEN AND COVERED IN TAPE FROM THE SHIPPING COMPANY. THE PRODUCT INSIDE HAD THE STERILIZATION FIELD COMPROMISED AND CAN'T BE USED ANYMORE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO ANOMALIES OR DAMAGE IN THE DEVICE. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, THE BOX OF THE DEVICE WAS DAMAGED; HOWEVER, THE PACKAGE WAS NOT RETURNED AND FURTHER INVESTIGATION COULD NOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE 31144123M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. BASED ON THE COMPLETED MRE, THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED WITH APPROPRIATE INFORMATION. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED DURING THE PRODUCT INVESTIGATION. OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. H 6. INVESTIGATION CONCLUSIONS CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (D17)¿ REFERS TO UNABLE TO ANALYZE DUE TO PRODUCT RETURNED CONDITION. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2023-02816 FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER). (2) MFR # 2029046-2023-02817 FOR PRODUCT CODE R7F282CT (DECANAV ELECTROPHYSIOLOGY CATHETER).

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTION TO THE INITIAL AND SUPPLEMENTAL MDR, INCOMPLETE UDI WAS PROVIDED. SECTION D4. PRIMARY UDI NUMBER HAS BEEN UPDATED WITH FULL UDI (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A DECANAV ELECTROPHYSIOLOGY CATHETER. IT WAS REPORTED THAT AFTER RECEIVING THE SHIPMENT OF NEW PRODUCTS, TWO OF THE BOXES WERE COMPLETELY BROKEN AND COVERED IN TAPE FROM THE SHIPPING COMPANY. THE PRODUCT INSIDE HAD THE STERILIZATION FIELD COMPROMISED AND CAN'T BE USED ANYMORE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231328 DECANAV ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31144123M 10846835008807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown THMCL SMTCH SF BID, TC, D-F