BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 9586451 · Received January 14, 2020

    Report

    Report Number
    2029046-2020-00086
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    December 18, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835008500
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING PULMONARY VEIN ISOLATION PROCEDURE IN A MALE PATIENT USING THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND MEDICAL DEVICE ENTRAPMENT, CATHETER TIP SEPARATION, AND HEMOSTATIC VALVE SEPARATION ISSUES OCCURRED. THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED THE DEVICE FOR EVALUATION ON (B)(6)2020 . UPON INITIAL INSPECTION, A KINK 30 INCHES FROM THE DOME WAS OBSERVED IN THE SHAFT. ADDITIONALLY, EXPOSED WIRES WERE OBSERVED 2 INCHES FROM THE DOME. THE OBSERVED KINK WITH EXPOSED WIRES HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION, AS THE DEVICE INTEGRITY WAS COMPROMISED. THE INVESTIGATIONAL ANALYSIS COMPLETED (B)(6)2020 . DURING THE SECOND VISUAL THE SHAFT WAS OBSERVED KINKED AND THE TIP WAS OBSERVED BROKEN WITH EXPOSED WIRES. THEN, THE CATHETER OUTER DIAMETER WAS MEASURED AND IT WAS FOUND WITHIN SPECIFICATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CUSTOMER COMPLAINT REGARDING CATHETER DAMAGE WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON TIP AND KINK IN THE SHAFT CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PULMONARY VEIN ISOLATION PROCEDURE IN A MALE PATIENT USING THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND MEDICAL DEVICE ENTRAPMENT, CATHETER TIP SEPARATION, AND HEMOSTATIC VALVE SEPARATION ISSUES OCCURRED. THE CATHETER BECAME ENTRAPPED IN THE SHEATH REQUIRING SNARE TO REMOVE. DURING REMOVAL MINOR BLEEDING OCCURRED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THE COMPLAINT CATHETER WAS PASSED FROM THE LEFT INTERNAL CAROTID ARTERY VIA THE 8.5FR SHEATH, WHICH WAS BENT 180 DEGREES FOR PULMONARY VEIN ISOLATION AND THE CATHETER BECAME STUCK IN THE UNKNOWN SHEATH. THE PHYSICIAN COULD NOT PUSH AND PULL. ATTEMPTS TO REMOVE THE CATHETER LED TO THE PROXIMAL SIDE OF THE MAGNET OF THE SHEATH¿S TIP TO COME OFF, BUT THE CATHETER COULD NOT BE MOVED FURTHER. A SNARE TOOL WAS THEN USED TO STRENGTHEN THE SHEATH AND THE CATHETER WAS REMOVE. WHEN THE CATHETER WAS REMOVED THERE WAS MATERIAL ATTACHED TO THE TIP: (¿WHITE VINYL¿) AT THE 74CM SHAFT FROM THE TIP OF THE CATHETER. THE MAGNET ON THE PROXIMAL SIDE WAS BROKEN, AND CONNECTED ONLY BY A WIRE. THE WHITE VINYL PART ON THE SHAFT OF THE CATHETER IS MOST PROBABLY HEMOSTATIC VALVE THAT BECAME DETACHED FROM THE SHEATH. WHEN THE CATHETER WAS REMOVED, BLOOD LEAKED FROM THE SHEATH HEMOSTASIS VALVE. THEREFORE, ONLY THE WIRE WAS LEFT AND THE SHEATH WAS REMOVED. THERE WERE NO COMPLICATIONS AND THE PATIENT RETURNED TO THE WARD AFTER THE PROCEDURE. THEREAFTER, THE INTERNAL CAROTID ARTERY WAS COMPRESSED AND HEMOSTATIC. AFTER CHANGING THE SHEATH AND THE CATHETER, THE PHYSICIAN USED TRANS-AORTIC APPROACH FROM THE INGUINAL ARTERY AND THE PROCEDURE WAS CONTINUED. AFTER THE COMPLETION OF PULMONARY VEIN ISOLATION, THE PROCEDURE COMPLETED SUCCESSFULLY. THE PHYSICIAN¿S COMMENTED THAT IN THE BEGINNING OF ABLATION, THERE WAS NO ABNORMALITY IN EITHER THE SHEATH OR THE CATHETER. THE SHEATH WAS BENT 180 DEGREES, AND THE CATHETER WAS PUSHED AND PULLED, AND IT WAS FELT CAUGHT. THE CATHETER DAMAGE MIGHT HAVE OCCURRED WHEN THE CATHETER WAS BEING REMOVED FROM THE SHEATH. THE DAMAGE COULD NOT HAVE OCCURRED BEFORE. THE OBSERVED MEDICAL DEVICE ENTRAPMENT, CATHETER TIP SEPARATION, AND HEMOSTATIC VALVE SEPARATION ISSUES HAVE BEEN ASSESSED AS MDR REPORTABLE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48833 NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC NR7TCSIY 30204513M 10846835008500

    Patients

    Seq Age Sex Outcome Treatment
    1