BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    MDR report key: 21472522 · Received February 26, 2025

    Report

    Report Number
    2029046-2025-00582
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    January 29, 2025
    Report Date
    April 25, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835004458
    PMA / PMN Number
    K892265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 1-APR-2025, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. MRE REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31510706M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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

    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 (SVT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID AND OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE DEVICES GOT ENTANGLED DURING THE PROCEDURE. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE OPTRELL CATHETER FROM THE VIZIGO SHEATH WHEN THE WEBSTER QUAD--THAT WAS IN THE HEART--GOT ENSNARED IN THE OPTRELL CATHETER GRID. MEANWHILE, THE OPTRELL CATHETER WAS STUCK IN THE SHEATH AND PULLED THE WEBSTER QUAD INTO THE SHEATH WITH IT. THIS EVENT DID NOT CAUSE AN INJURY TO THE PATIENT BUT WAS MORE OF A "HOLD UP" OR DELAY IN THE PROCEDURE. THE PHYSICIAN WASN'T QUITE SURE WHAT TO DO SO THEY ENDED UP CUTTING THE WEBSTER QUAD CATHETER AT THE HANDLE AND PULLED IT OUT OF THE BODY. DUE TO THE MULTIPLE MORPHOLOGIES, THE PROCEDURE WAS ABORTED AFTER THE CATHETERS WERE REMOVED FROM THE BODY. NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS UNDER AESTHESIA FOR AN UNKNOWN AMOUNT OF TIME. NO TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO CASE CANCELLATION. THE PATIENT'S LAST KNOWN STATUS WAS STABLE. THIS REPORT IS FOR THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID. A SEPARATE REPORT WILL BE SENT FOR THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617448 WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31510706M 10846835004458

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8.5F SHEATH WITH CURVE VIZ MDC| UNK_CARTO 3