BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 18244371 · Received December 1, 2023

    Report

    Report Number
    2029046-2023-02800
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 3, 2023
    Report Date
    February 1, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 09-JAN-2024. IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND AFTER THE CATHETER WAS TAKEN OUT OF THE BODY, THE TIP OF THE CATHETER WAS BROKEN. THE TIP SEEMED A BIT DISCONNECTED BUT STILL ATTACHED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INSPECTION WAS PERFORMED AND A HOLE ON THE SURFACE AND REDDISH MATERIAL INSIDE THE PEBAX WERE OBSERVED. THE DAMAGE ON THE PEBAX COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED DURING PRODUCT ANALYSIS, THE LOT NUMBER WAS VERIFIED TO BE (B)(4). THIS WAS VERIFIED BY ELECTRONICALLY ERASABLE PROGRAMMABLE READ ONLY MEMORY (EEPROM) FILE. THEREFORE, D4. LOT HAS BEEN POPULATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31172502L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ADDITIONALLY, THE MANUFACTURED AND EXPIRATION DATES HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE DAMAGE ON THE PEBAX'S SURFACE COULD BE RELATED TO THE BROKEN TIP ISSUE DESCRIBED BY THE CUSTOMER. IT SHOULD BE NOTED THAT DEVICE FAILURE IS MULTIFACTORIAL. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND AFTER THE CATHETER WAS TAKEN OUT OF THE BODY, THE TIP OF THE CATHETER WAS BROKEN. THE TIP SEEMED A BIT DISCONNECTED BUT STILL ATTACHED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632969 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31172502L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ MDC.