BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 14059556 · Received April 8, 2022

    Report

    Report Number
    2029046-2022-00764
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 15, 2022
    Report Date
    August 25, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835000177
    PMA / PMN Number
    K892265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 (B)(6) 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).

    Additional Manufacturer Narrative · 0

    ON 1-JUN-2022, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. DURING INSERTION OF THE CATHETER THE CATHETER WAS TWISTED AND DAMAGED. THE CATHETER WAS DIFFICULT TO REMOVE AND THE DOCTOR HAD TO DO SEVERAL MANEUVERS TO REMOVE IT. DEVICE EVALUATION DETAILS: VISUAL INSPECTION TESTING WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES AND THE CATHETER FAILED DUE TO THE SHAFT BEING FOUND BENT. A DIMENSIONAL TEST WAS PERFORMED, AND THE OUTER DIAMETERS OF THE DEVICE WERE FOUND WITHIN SPECIFICATIONS. THERE IS NO CONDITION ON THE CATHETER THAT COULD BE RELATED TO THE ENTRAPMENT OF THE CATHETER DURING THE PROCEDURE. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30658055L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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 THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. DURING INSERTION OF THE CATHETER THE CATHETER WAS TWISTED AND DAMAGED. THE CATHETER WAS DIFFICULT TO REMOVE AND THE DOCTOR HAD TO DO SEVERAL MANEUVERS TO REMOVE IT. THE DOCTOR WAS RAISING THE CATHETER INTO THE PATIENT, AND SUDDENLY THE CATHETER WAS TWISTED AND DAMAGED AND THE DOCTOR HAD TO DO SEVERAL MANEUVERS TO REMOVE IT. HE WAS FINALLY BEEN ABLE TO REMOVE IT FROM THE PATIENT WITHOUT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DAMAGE DID NOT RESULT IN WIRES/INTERNAL COMPONENTS BEING EXPOSED OR LIFTED OR SHARP RINGS. IT WAS DIFFICULT TO ADVANCE DURING THE INSERTION OF THE CATHETER TO THE CORONARY SINUS, SO PHYSICIAN DECIDE TO REMOVE THE CATHETER AND IT WAS DIFFICULT AS WELL BECAUSE HE NOTICED UNDER X-RAY CATHETER SHAPED WAS BENT. FINALLY HE WAS ABLE TO REMOVE THE CATHETER OUT THE PATIENT. THE DOCTOR ALWAYS PRE-SHAPES THE CATHETER BEFORE INSERTION. THE SHEATH USED WAS A ABBOTT SHORT SHEATH 5FR. SHAFT BENT IS NOT MDR-REPORTABLE. MEDICAL DEVICE ENTRAPMENT WITH EXCESSIVE MANIPULATION REQUIRED IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439759 WEBSTER¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 1085122RT 30658055L 10846835000177
    827046 WEBSTER¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 1085122RT 30658055L 10846835000177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ABBOTT SHORT SHEATH 5FR.