BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE

    MDR report key: 15584468 · Received October 11, 2022

    Report

    Report Number
    2029046-2022-02482
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 12, 2022
    Report Date
    December 9, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021127
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #(B)(4). CORRECTION: ON 9-DEC-2022, IT WAS NOTICED THE CODE OF ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY (B15) WAS INADVERTENTLY OMITTED FROM FIELD H6. TYPE OF INVESTIGATION OF THE 3500A SUPPLEMENTAL (FOLLOW-UP) # 1. AS SUCH, THE CODE HAS NOW BEEN ADDED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE AND AN ISSUE OF FOREIGN MATERIAL WAS ENCOUNTERED. WHEN THE OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE WAS REMOVED FROM THE BAYLISS SHEATH, A LINE THAT APPEARED TO BE A PART OF THE BAYLISS SHEATH WAS ENTANGLED WITH THE OCTARAY CATHETER SPLINES. WHEN IT WAS INITIALLY BROUGHT OUT, THE PIECE APPEARED SIMILAR TO A "FISHING LINE," BUT THAT IT APPEARED TO BE PLASTIC. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI CONDUCTED A VISUAL INSPECTION AND IRRIGATION TEST ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT 2 ELECTRODES # 3 AND # 4 WERE OBSERVED LIFTED WITHOUT POLYURETHANE (PU) ON THE EDGE, NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED ON THE OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE. NO FOREIGN MATERIAL WAS RETURNED; THEREFORE, WE ARE UNABLE TO ANALYZE THE FOREIGN MATERIAL. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER FOREIGN MATERIAL WAS OBSERVED INSIDE OF A PLASTIC BAG. THE MATERIAL LOOKS LIKE A PLASTIC THREAD. ALTHOUGH THE CATHETER WAS NOT OBSERVED ON THE PICTURE PROVIDED, THE APPEARANCE OF THE MATERIAL MATCHES WITH THE CUSTOMER DESCRIPTION AND WHICH COULD HAVE BEEN DAMAGE BY THE DAMAGED ELECTRODES. THE CUSTOMER COMPLAINT RELATED TO FOREIGN MATERIAL COULD ONLY BE CONFIRMED BASED ON THE PICTURE RECEIVED. THE ELECTRODE DAMAGE ISSUE IDENTIFIED BY THE PAL IS CONSIDERED TO BE AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE IS NOT MAINTAINED AND INTERNAL COMPONENTS COULD BE EXPOSED TO PATIENT AND THE RINGS EDGES MIGHT BE SHARP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF BWI'S QUALITY PROCESS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE FOREIGN MATERIAL INVESTIGATION FINDINGS: MECHANICAL PROBLEMS IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ELECTRODE (G0201501) WERE SELECTED AS RELATED TO THE DAMAGED ELECTRODES. MANUFACTURER'S REF. # (B)(4) CORRECTION: IT WAS NOTICED THE "BAYLIS SHEATH" WAS INADVERTENTLY OMITTED FROM THE 3500A INITIAL MDR AND HAS NOW BEEN ADDED TO SECTION D10. CONCOMITANT MED PRODUCTS

    Additional Manufacturer Narrative · 0

    ON 11-OCT-2022, 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. 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 (AFIB) ABLATION PROCEDURE WITH AN OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE AND AN ISSUE OF FOREIGN MATERIAL WAS ENCOUNTERED. WHEN THE OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE WAS REMOVED FROM THE BAYLISS SHEATH, A LINE THAT APPEARED TO BE A PART OF THE BAYLESS SHEATH WAS ENTANGLED WITH THE OCTARAY CATHETER SPLINES. WHEN IT WAS INITIALLY BROUGHT OUT, THE PIECE APPEARED SIMILAR TO A "FISHING LINE," BUT THAT IT APPEARED TO BE PLASTIC. THE ISSUE WAS NOTICED AT THE END OF THE CASE, AFTER USE OF THE OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE; THE CATHETER WAS USED ON THE PATIENT. THE LINE WAS DESCRIBED AS WHITE/CLEAR, LONG, CURLY AND LOOKS LIKE A LONG SHAVING FROM THE INNER COATING OF A SHEATH. THE DOCTOR STATED THAT IT DID NOT LOOK LIKE IT CAME FROM THE CATHETER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2880046 OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D160903 30786288L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BAYLIS SHEATH| SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US