BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 19806959 · Received July 23, 2024

    Report

    Report Number
    2029046-2024-02464
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 26, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED AFTER THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN DOES NOT USE SOUNDSTAR® ULTRASOUND BUT USES A TRANSTHORACIC ECHO (TE) PROBE. AFTER VERIFYING WITH THE PROBE THE ISSUE WAS CONFIRMED. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION, AWAKE, AND HEADING TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. AFTER LOOKING AT THE LESION IN REAL TIME THEY BELIEVE TO HAVE FOUND THE SPECIFIC PLOT BY THE SEPTUM BY THE RIGHT SUPERIOR VEIN. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. ON (B)(6) 2024, DURING PRODUCT INVESTIGATION, THE LOT NUMBER FOR THE DEVICE WAS IDENTIFIED TO BE 31321003L. AS SUCH FIELD D4 LOT HAS BEEN POPULATED AND A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS, OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNING AND PRECAUTIONS: WHEN USING THE CATHETER WITH CONVENTIONAL SYSTEMS (USING FLUOROSCOPY TO DETERMINE CATHETER TIP LOCATION), OR WITH THE CARTO¿ 3 SYSTEM, CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED. THE FIRMNESS OF THE BRAIDED TIP DICTATES THAT CARE MUST BE TAKEN TO PREVENT PERFORATION OF THE HEART. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NOTE: THE FULL UDI HAS NOW BEEN PROVIDED UNDER FIELD D4. PRIMARY UDI NUMBER. 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

    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. D4: UDI: THE MANUFACTURING AND EXPIRATION DATES ARE CURRENTLY UNAVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED AFTER THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN DOES NOT USE SOUNDSTAR® ULTRASOUND BUT USES A TRANSTHORACIC ECHO (TE) PROBE. AFTER VERIFYING WITH THE PROBE THE ISSUE WAS CONFIRMED. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION, AWAKE, AND HEADING TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. AFTER LOOKING AT THE LESION IN REAL TIME THEY BELIEVE TO HAVE FOUND THE SPECIFIC PLOT BY THE SEPTUM BY THE RIGHT SUPERIOR VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046468 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31321003L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R NGEN RF GENERATOR KIT.| TRANSTHORACIC ECHO (TE) PROBE.