BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECANAV

    MDR report key: 23919208 · Received December 29, 2025

    Report

    Report Number
    2029046-2025-04342
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    October 14, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    K080425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED AS A BWI DEVICE AND REPORTED UNDER 2029046-2025-04342. HOWEVER, DURING ANALYSIS OF THE DEVICE BY BWI ON 14-JAN-2026, IT WAS DETERMINED THAT THE DEVICE WAS ACTUALLY A REPROCESSED STERILMED INC. DEVICE. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE FOR BWI. THIS EVENT HAS NOW BEEN REPORTED BY STERILMED INC. UNDER 2134070-2026-00002. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 24-NOV-2025. 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. 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 A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A DECANAV CATHETER AND OBSERVED GAUZE AT THE TIP OF THE CATHETER. THE PHYSICIAN FELT LIKE THE DECANAV CATHETER WAS NOT MANEUVERING SMOOTHLY. WHEN THE DECANAV CATHETER WAS REMOVED FROM THE BODY, THE CATHETER SEEMED ROUGH AT THE TIP OF THE CATHETER. THE DECANAV CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THE FAULTY DECANAV CATHETER WAS REPROCESSED BY STERILMED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 21-NOV-2025 WHICH CORRECTED THAT THE DEVICE RECEIVED AT THE BIOSENSE WEBSTER, INC. (BWI) PRODUCT ANALYSIS LAB MUST BE THE BWI DECANAV CATHETER THAT HAD THE ISSUE AS THERE WERE NO OTHER DECANAV CATHETER¿S CALLED IN FROM THIS ACCOUNT IN THE LAST 30 DAYS. ADDITIONAL INFORMATION WAS RECEIVED ON 24-NOV-2025. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS RESISTANCE ON REMOVAL SLIGHTLY. TISSUE WAS FOUND ON THE VERY DISTAL TOP OF THE CATHETER. THE SHEATH USED WAS AN 8FR PINNACLE SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 04-DEC-2025. THE PHYSICIAN FELT THERE WAS SOMETHING WRONG WITH THE TIP OF THE CATHETER. DOES NOT KNOW IF IT WAS TISSUE OR PART OF A GAUZE. CALLER STATED NEVER SAW IT BEFORE IT WAS WIPED. ASKED THE PHYSICIAN IF HE REMEMBERED BUT HE SAID THE ISSUE HAPPENED SO LONG AGO THAT HE DOES NOT RECALL. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 04-DEC-2025 THAT THE PHYSICIAN FELT THERE WAS SOMETHING WRONG WITH THE TIP OF THE CATHETER AND DID NOT KNOW IF IT WAS TISSUE OR PART OF A GAUZE. THEREFORE, HAVE ASSESSED THIS INFORMATION AS REPORTABLE FOR FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER. THE REPORTABLE AWARENESS DATE FOR THIS RECORD IS 04-DEC-2025 BECAUSE OF THE GAUZE AT THE TIP OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183301 DECANAV CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8FR PINNACLE SHEATH.| CARTO 3 SYSTEM.| THMCL SMTCH SF BID, TC, D-F.| UNK ABLATION CABLE.| UNK GREEN PATCH CABLE.| UNK YELLOW PATCH CABLE.| UNK_NGEN RF GENERATOR.