BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 13482087 · Received February 8, 2022

    Report

    Report Number
    2029046-2022-00242
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 19, 2022
    Report Date
    April 10, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). 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

    ON 21-MAR-2022, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE ELECTRODE WAS CAUGHT IN MECHANICAL VALVE AND CUT OFF CAUSING A FOREIGN BODY. PENTARAY NAV ECO CATHETER'S ELECTRODE WAS CAUGHT OFF THE MECHANICAL VALVE AND REMAINED IN THE PATIENT'S BODY. THIS OCCURRED AFTER 1HOUR SINCE THE PROCEDURE WAS STARTED, DURING PRE VOLTAGE MAP REMAINING OF PENTARAY NAV ECO CATHETER ELECTRODE IN THE PATIENT'S BODY. THERE WAS NO SPECIFIC HEALTH INJURY TO THE PATIENT. DEVICE EVALUATION DETAILS: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DISTAL SIDE OF THE SPINE WAS FOUND DETACHED, THE DETACHED AREA PRESENTED ELONGATION, THREE ELECTRODES WERE MISSING AND INTERNAL COMPONENTS ARE EXPOSED IN THE TIP AREA ON THE PENTARAY NAV ECO CATHETER. ALL UNITS ARE INSPECTED PRIOR TO LEAVING THE FACILITY AS THERE ARE FUNCTIONAL TESTS AND INSPECTIONS AT CONTROL POINTS BASED ON THE PROCESS FLOW DIAGRAM (PFD) PER ITS PART NUMBER TO AVOID THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30477790L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ROOT CAUSE OF SPLINE DETACHED COULD BE RELATED TO THE USE OF PENTARAY CATHETER IN A PATIENT WITH A MECHANICAL VALVE, SINCE THE PHYSICIAN COMMENTED THAT PENTARAY NAV ECO CATHETER'S SPINE WAS CAUGHT ON THE MECHANICAL VALVE, THE THREE ELECTRODES WERE DETACHED, FLOATING INTO THE LEFT ATRIUM, THE LEFT VENTRICLE, AND THE DESCENDING AORTA, AND STOPPED AT THE ARTERY TO THE PLEURA AND THE ARTERY TO THE BRONCHUS. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING STATEMENT: USE OF THIS CATHETER IS NOT APPROPRIATE FOR USE IN PATIENTS WITH PROSTHETIC VALVES. 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

    ON 18-FEB-2022, THE BWI 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE ELECTRODE WAS CAUGHT IN MECHANICAL VALVE AND CUT OFF CAUSING A FOREIGN BODY. PENTARAY NAV ECO CATHETER'S ELECTRODE WAS CAUGHT OFF THE MECHANICAL VALVE AND REMAINED IN THE PATIENT'S BODY. THIS OCCURRED AFTER 1HOUR SINCE THE PROCEDURE WAS STARTED, DURING PRE VOLTAGE MAP. REMAINING OF PENTARAY NAV ECO CATHETER ELECTRODE IN THE PATIENT'S BODY. THERE WAS NO SPECIFIC HEALTH INJURY TO THE PATIENT. THE PHYSICIAN COMMENTED THAT PENTARAY NAV ECO CATHETER 'S SPINE WAS CAUGHT ON THE MECHANICAL VALVE, THE THREE ELECTRODES WERE DETACHED, FLOATING INTO THE LEFT ATRIUM, THE LEFT VENTRICLE, AND THE DESCENDING AORTA, AND STOPPED AT THE ARTERY TO THE PLEURA AND THE ARTERY TO THE BRONCHUS. BOTH BLOOD VESSELS WERE JUDGED TO HAVE NO SIGNIFICANT EFFECT ON THE PATIENT'S HEALTH, AND THE PATIENT LEFT THE ROOM WITH THE LEFT ELECTRODES. THE PHYSICIAN COMMENTED THAT THE 2 OF REMAINING ELECTRODES REMAINED IN THE INTERCOSTAL ARTERY AND THE OTHER REMAINED IN LEFT VENTRICLE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS THE PROCEDURE. NO INTERVENTION IS PLANNED. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS UNCHANGED. GENERATOR INFORMATION: SMARTABLATE. SINCE THE EVENT IS LIFE THREATENING AND MAY REQUIRE INTERVENTION PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776494 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128211 30477790L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 Male SMARTABLATE GENERATOR