BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV

    MDR report key: 21624120 · Received March 17, 2025

    Report

    Report Number
    2029046-2025-00811
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 17, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31525761L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A PENTARAY NAV AND THE PATIENT EXPERIENCED FOREIGN BODY. IT WAS REPORTED THAT A SPLINE OF THE PENTARAY NAV BECAME CAUGHT ON THE PATIENT'S MECHANICAL MITRAL VALVE AND HALF OF THE PENTARAY NAV SPLINE WAS CUT AND DETACHED FROM THE PENTARAY NAV. THEY HAD ALREADY COMPLETED ABLATION OF THE ATRIAL FIBRILLATION AND FOLLOWING ABLATION, THE PATIENT HAD GONE INTO "MITRAL" FLUTTER. THE PHYSICIAN WAS CAREFULLY MAPPING AROUND THE MITRAL VALVE USING THE PENTARAY NAV. THE PENTARAY NAV FELT STUCK AND THE PHYSICIAN TUGGED SOME ON THE PENTARAY NAV. WHEN THE PENTARAY NAV WAS REMOVED FROM THE BODY, IT APPEARED THAT ONE OF THE 5-ELECTRODE SPLINES WAS MISSING POTENTIALLY 3 ELECTRODES. THE PATIENT WAS CARDIOVERTED AND THE PHYSICIAN DID NOT ABLATE THE FLUTTER. THE CASE WAS ABORTED AND THE CATHETERS WERE PULLED. AN X-RAY WAS USED ON THE PATIENT'S ENTIRE BODY BUT THE SPLINE OF THE PENTARAY NAV WAS UNABLE TO BE LOCATED. IT WAS BELIEVED THAT A CT WOULD BE PERFORMED ON THE PATIENT BUT THAT HE WAS UNSURE. NO MEDICAL INTERVENTION HAD BEEN PERFORMED. THE PATIENT WAS SUPPOSED TO BE AN OUTPATIENT PROCEDURE; HOWEVER, THE PATIENT WOULD BE MONITORED OVERNIGHT, ESPECIALLY TO MONITOR FOR STROKE SYMPTOMS. THE PATIENT'S LAST KNOWN STATUS WAS STABLE. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. WHEN THE INJURY OCCURRED, THE PENTARAY NAV WAS IN THE LEFT ATRIUM AND THE SOUNDSTAR CATHETER AND CORONARY SINUS CATHETER WERE IN THE RIGHT ATRIUM. THE SMARTTOUCH SF CATHETER WAS USED FOR ABLATION BUT WAS OUTSIDE OF THE BODY WHEN THE INJURY OCCURRED. A TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE CASE CANCELLATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE, THAT THE PATIENT HAD MITRAL FLUTTER AND HE GOT TOO CLOSE TO THE PROSTHETIC VALVE. IN THE PHYSICIAN¿S OPINION, THE CASE CANCELATION DID NOT CONTRIBUTE TO A DEATH OR A SERIOUS INJURY TO THE PATIENT. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR ABOUT 90 MINUTES. THE DAMAGE RESULTED IN ONE SPLINE HAD TWO ELECTRODES MISSING WHICH EXPOSED WIRES. 1/5 SPLINES HALF OF THE SPLINE WAS CUT OFF. IT WAS REPORTED THAT PARTIAL DETACHMENT WAS EVIDENT, NOT TOTAL. NO RESISTANCE. JUST GOT STUCK ON THE MITRAL VALVE. ADDITIONAL INFORMATION WAS RECEIVED. WHILE MAPPING AN ATYPICAL FLUTTER RHYTHM, THE SPLINE FROM THE PENTARAY NAV WAS NOTED TO BE MISSING UPON REMOVAL. THE DISTAL TIP OF THE PENTARAY NAV SPLINE WAS SHORN OFF AND NO LONGER PART OF THE CATHETER. THE OUTCOME ATTRIBUTED TO THE ADVERSE EVENT WAS HOSPITALIZATION. THE MEDICAL DEVICE ENTRAPMENT WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION. THE DETACHED SPLINE WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION. THE SPLINE OF THE PENTARAY NAV WAS UNABLE TO BE LOCATED WITHIN THE PATIENT WITH PROLONGED HOSPITALIZATION WAS ASSESSED AS MDR REPORTABLE FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283775 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31525761L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization CARTO 3 SYSTEM.| CORONARY SINUS CATHETER.| NGEN RF GENERATOR, US.| SMARTTOUCH SF CATHETER.| SOUNDSTAR CATHETER.