BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 8577654 · Received May 3, 2019

    Report

    Report Number
    2029046-2019-03056
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 3, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE ON WHICH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS USED, AND MEDICAL DEVICE ENTRAPMENT WITH EXCESSIVE MANIPULATION OCCURRED AND TWO OF THE SPLINES WERE FULLY SEPARATED REQUIRING SURGICAL INTERVENTION. AFTER TRANSSEPTAL PUNCTURE, DURING LEFT ATRIUM MAPPING, THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER GOT STUCK IN THE ANNULUS OF THE ARTIFICIAL MITRAL VALVE. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER COULD BE REMOVED BY USING A SNARE CATHETER. UPON CATHETER REMOVAL, TWO PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER SPLINES WERE BROKEN, ONE WAS FOUND INSIDE THE LEFT INFERIOR PULMONARY VEIN (LIPV) AND IT WAS REMOVED. THE OTHER SPLINE MOVED TO DEEP FEMORAL ARTERY, PHYSICIAN DECIDED TO LEAVE IT IN THERE AS IT WAS JUDGED THAT THE POSSIBILITY OF DEVELOPING A CEREBRAL INFRACTION WAS LOW. THE PATIENT¿S BLOOD PRESSURE WAS STABLE. PULMONARY VEIN ISOLATION (PVI) AND ATRIAL TACHYCARDIA (AT) ABLATION WERE COMPLETED AFTER THE CATHETER WAS REMOVED. THE PATIENT WAS REPORTED IN STABLE CONDITION. THE DEVICE WAS INSPECTED, AND TWO SPLINES WERE OBSERVED DETACHED FROM THE TIP, AND TWO RINGS WERE OBSERVED TO BE SQUASHED. THEN, MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, DEFLECTION TEST WAS PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS DEFLECTING CORRECTLY. THEN, IRRIGATION TEST WAS PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING CORRECTLY, NO IRRIGATION ISSUES WERE OBSERVED. THE ELECTRICAL TEST FAILED DUE TO THE MISSING SPLINES. THEN, THE CATHETER OUTER DIAMETER WAS MEASURED, AND IT WAS FOUND WITHIN SPECIFICATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. USE OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS OFF-LABEL IN A PATIENT WITH MECHANICAL VALVE. DAMAGE TO THE VALVE AND POSSIBLE NEED FOR SURGICAL INTERVENTIONS ARE KNOWN COMPLICATIONS OF ITS USE IN MECHANICAL VALVES. THE ROOT CAUSE OF THE DAMAGE OBSERVED CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES, THIS ISSUE IS RELATED TO THE PROCEDURE. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON JUNE 4, 2020, A CORRECTION WAS IDENTIFIED UNDER THE 3500A INITIAL AS THE CODE OF ¿DEVICE FRAGMENTS IN PATIENT¿ WAS OMITTED. THEREFORE. PATIENT CODES TO REFLECT THIS CODE. IN ADDITION, CODE 2993/ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM ADDED IN THE 3500A INITIAL WAS ADDED IN ERROR. 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 · 1

    INITIAL REPORTER PHONE: (B)(6). (B)(4). THERE WAS REPORTED OFF-LABEL USE REPORTED IN THIS EVENT DESCRIPTION. THE USAGE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER IS CONTRAINDICATED IN PATIENTS WITH PROSTHETIC VALVES. THE BIOSENSE WEBSTER, INC. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30147352L NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE ON WHICH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS USED, AND MEDICAL DEVICE ENTRAPMENT WITH EXCESSIVE MANIPULATION OCCURRED AND TWO OF THE SPLINES WERE FULLY SEPARATED REQUIRING SURGICAL INTERVENTION. AFTER TRANSSEPTAL PUNCTURE, DURING LEFT ATRIUM MAPPING, THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER GOT STUCK IN THE ANNULUS OF THE ARTIFICIAL MITRAL VALVE. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER COULD BE REMOVED BY USING A SNARE CATHETER. UPON CATHETER REMOVAL, TWO PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER SPLINES WERE BROKEN, ONE WAS FOUND INSIDE THE LEFT INFERIOR PULMONARY VEIN (LIPV) AND IT WAS REMOVED. THE OTHER SPLINE MOVED TO DEEP FEMORAL ARTERY, PHYSICIAN DECIDED TO LEAVE IT IN THERE AS IT WAS JUDGED THAT THE POSSIBILITY OF DEVELOPING A CEREBRAL INFRACTION WAS LOW. THE PATIENT¿S BLOOD PRESSURE WAS STABLE. PULMONARY VEIN ISOLATION (PVI) AND ATRIAL TACHYCARDIA (AT) ABLATION WERE COMPLETED AFTER THE CATHETER WAS REMOVED. THE PATIENT WAS REPORTED IN STABLE CONDITION. THE ISSUES OF MEDICAL DEVICE ENTRAPMENT WITH EXCESSIVE MANIPULATION AND THE SPLINES FULLY SEPARATED WERE ASSESSED AS A REPORTABLE ISSUES. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON APRIL 30, 2019, AND THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS RETURNED IN THE CONDITION REPORTED AS B AND C HAVE BEEN SEVERED AND NOT RETURNED WITH THE PRODUCT. SPLINE D HAS TWO RINGS SQUASHED. THE RETURNED CONDITION OF THE SEVERED SPLINES REMAIN ASSESSED AS A REPORTABLE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371454 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128211 30147352L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1