BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 11852525 · Received May 19, 2021

    Report

    Report Number
    2029046-2021-00782
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 5/26/2021 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND IT WAS NOTICED THAT WHEN THE CATHETER WAS REMOVED FROM THE RIGHT ATRIUM, WHITE MATERIAL WAS COMING OFF OF THE CATHETER. NO ISSUES WITH MANEUVERING OR PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED ON 30-JUL-2021. ACCORDING TO THE PICTURES PROVIDED BY CUSTOMER, FOREIGN MATERIAL WAS OBSERVED ON THE TIP OF THE PENTARAY. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURES RECEIVED. 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 A FOREIGN WHITE MATERIAL ON SPINES WAS OBSERVED ON THE PENTARAY NAV HIGH-DENSITY MAPPING 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. VISUAL TEST WAS PERFORMED, AND THE FOREIGN WHITE MATERIAL WAS OBSERVED ON SPINE. THE SAMPLE WAS SENT TO THE LABORATORY FOR ANALYSIS, AND THE FOURIER TRANSFORM INFRARED SPECTROSCOPY TEST (FT-IR) REVEALED THE SAMPLE IS PRESUMABLY HUMAN TISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30510177L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE ROOT CAUSE OF FOREIGN WHITE MATERIAL COULD BE RELATED WITH THE HANDLING OF THE DEVICE DURING THE PROCEDURE. 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

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) DURING AN INTERNAL REVIEW ON 25-AUG-2021, IT WAS NOTICED THAT A STATEMENT REGARDING THE INVESTIGATION FINDINGS CODE WAS INADVERTENTLY LEFT OFF. H6. INVESTIGATION FINDINGS CODE OF "APPROPRIATE TERM/CODE NOT AVAILABLE" REPRESENTS PHOTO/VIDEO ANALYSIS.

    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) DURING AN INTERNAL REVIEW ON (B)(6)-2021, IT WAS OBSERVED THAT THE CORRECT PRODUCT EXPERIENCE CODE SHOULD HAVE BEEN FOREIGN MATERIAL ON USABLE LENGTH OF CATHETER INSTEAD OF THE PREVIOUSLY REPORTED INTERNAL COMPONENTS EXPOSED. THEREFORE, H6. MEDICAL DEVICE PROBLEM CODE HAS BEEN UPDATED FROM MATERIAL PROTRUSION / EXTRUSION (A0411) TO CONTAMINATION / DECONTAMINATION PROBLEM (A18). THE AWARENESS DATE IS (B)(6)-2021.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND AN INTERNAL COMPONENTS EXPOSED ISSUE OCCURRED. IT WAS NOTICED THAT WHEN THE CATHETER WAS REMOVED FROM THE RIGHT ATRIUM, WHITE MATERIAL WAS COMING OFF OF THE CATHETER. NO ISSUES WITH MANEUVERING OR PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THIS ISSUE WAS ASSESSED AS MDR REPORTABLE, INTERNAL COMPONENTS EXPOSED ISSUE. THE RISK TO THE PATIENT IS CRITICAL DUE TO THE POTENTIAL OF THROMBUS FROM EXPOSURE OF INTERNAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746762 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128208 30510177L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 AGILIS SHEATH 8.5F.