BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY

    MDR report key: 12961572 · Received December 8, 2021

    Report

    Report Number
    2029046-2021-02136
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 15, 2021
    Report Date
    February 23, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002416
    PMA / PMN Number
    K090898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 26-JAN-2022. THE DEVICE EVALUATION WAS COMPLETED ON 08-FEB-2022. IT WAS REPORTED THAT A PATIENT WAS GOING TO UNDERGO AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND A FOREIGN MATERIAL WAS FOUND IN THE CS CATHETER STERILE PACKAGING. IT WAS REPORTED THAT INSIDE THE STERILE CS CATHETER PACKAGING, THERE WAS A LITTLE PIECE OF FUZZ IN IT. THE FOREIGN MATERIAL APPEARED TO BE A SMALL BLACK PIECE OF FUZZ, BUT THE PACKAGE WAS NOT OPENED AFTER NOTICING THIS. THE CATHETER WAS NOT USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC. (BWI) FOR EVALUATION. BWI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE WEBSTER ® CS CATHETER. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, FOREIGN MATERIAL APPEARS INSIDE THE POUCH. HOWEVER, THE DEVICE WAS RETURNED WITHOUT ITS ORIGINAL PACKAGE; THEREFORE, THE TEST CANNOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [30655129M] NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF BWI'S QUALITY PROCESS. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: INSPECT THE CATHETER PACKAGING BEFORE USE. IF THE PACKAGE IS OPEN OR DAMAGED, RETURN THE CATHETER TO BIOSENSE WEBSTER. 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

    THE PHOTO ANALYSIS WAS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT A PATIENT WAS GOING TO UNDERGO AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND A FOREIGN MATERIAL WAS FOUND IN THE CS CATHETER STERILE PACKAGING. IT WAS REPORTED THAT INSIDE THE STERILE CS CATHETER PACKAGING, THERE WAS A LITTLE PIECE OF FUZZ IN IT. THE FOREIGN MATERIAL APPEARED TO BE A SMALL BLACK PIECE OF FUZZ BUT THE PACKAGE WAS NOT OPENED AFTER NOTICING THIS. THE CATHETER WAS NOT USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ACCORDING TO THE PICTURES PROVIDED BY THE CUSTOMER, FOREIGN MATERIAL APPEARED TO BE INSIDE THE POUCH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [30655129M] NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED FROM THE PHOTO ANALYSIS. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SINCE NO DEVICE HAS BEEN RECEIVED, NO PRODUCT INVESTIGATION CAN BE PERFORMED. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT ANALYSIS WILL BE PERFORMED AS APPROPRIATE IN ORDER TO FIND THE ROOT CAUSE OF THE COMPLAINT. H6. INVESTIGATION FINDINGS CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE¿ REPRESENTS PHOTO/VIDEO ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: PC-(B)(4). .

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, HOWEVER, PICTURES WERE PROVIDED BY THE CUSTOMER. EVALUATION IS STILL IN PROGRESS. 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. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS GOING TO UNDERGO AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND A FOREIGN MATERIAL WAS FOUND IN THE CS CATHETER STERILE PACKAGING. IT WAS REPORTED THAT INSIDE THE STERILE CS CATHETER PACKAGING, THERE WAS A LITTLE PIECE OF FUZZ IN IT. THE FOREIGN MATERIAL APPEARED TO BE A SMALL BLACK PIECE OF FUZZ BUT THE PACKAGE WAS NOT OPENED AFTER NOTICING THIS. THE CATHETER WAS NOT USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE FOREIGN MATERIAL INSIDE THE PACKAGING (OUTSIDE OF SPEC) WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860506 WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER INC BD710DF282RTS 30655129M 10846835002416

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown