BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL

    MDR report key: 22801301 · Received August 13, 2025

    Report

    Report Number
    2029046-2025-02688
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 21, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835023015
    PMA / PMN Number
    K211438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OPTRELL AND THE CATHETER BECAME CAUGHT ON THE ON THE ABBOTT SUPREME QUAD CATHETER. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL INSPECTION WAS PERFORMED, AND THE PADDLE'S SPLINES WERE OBSERVED BENT AND BROKEN WITH INTERNAL COMPONENTS EXPOSED. THE DAMAGE OBSERVED IS RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE AS CUSTOMER REPORTED. THE ENTRAPMENT ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ISSUE CANNOT BE ESTABLISHED. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING WARNING AND PRECAUTION: DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S DISTAL SPINES FOLDED BACKWARD TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH WHEN RESISTANCE IS ENCOUNTERED. PRIOR TO REMOVING OR REPOSITIONING THE CATHETER, USE DIRECT IMAGING GUIDANCE SUCH AS FLUOROSCOPY TO CONFIRM THAT THE SPINE ASSEMBLY IS NOT ENTANGLED WITH ANOTHER CATHETER OR WITH AN ANATOMICAL STRUCTURE. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 14-AUG-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OPTRELL AND THE CATHETER BECAME CAUGHT ON THE ON THE ABBOTT SUPREME QUAD CATHETER. IT WAS REPORTED THAT AFTER MAPPING THE ACCESSORY PATHWAY AND ATTEMPTING TO PULL THE OPTRELL CATHETER OUT OF THE BODY, THE OPTRELL CATHETER BECAME CAUGHT ON THE ABBOTT SUPREME QUAD CATHETER. THE CALLER REPORTED THAT THE OPTRELL CATHETER MADE IT INTO THE SHORT SHEATH BUT THE ABBOTT SUPREME QUAD CATHETER FOLDED OVER ON ITSELF AND BECAME STUCK INSIDE OF THE SHORT SHEATH WITH THE OPTRELL CATHETER. THE ISSUE WAS CONFIRMED ON FLUORO. AN INTERVENTIONAL RADIOLOGIST WAS CALLED IN AFTER MONITORING THE ISSUE ON FLUORO AND THE ELECTROPHYSIOLOGY (EP) PHYSICIAN WAS ABLE TO PULL THE SHORT SHEATH OUT TO EXPOSE THE OPTRELL CATHETER AND THE ABBOTT SUPREME QUAD CATHETER. THE CALLER REPORTED THAT THE OPTRELL CATHETER WAS THEN CUT TO FREE IT FROM THE ABBOTT SUPREME QUAD CATHETER. THE ABBOTT SUPREME QUAD CATHETER WAS CUT IN HALF AND ONE PART OF THE ABBOTT SUPREME QUAD CATHETER WAS PULLED FROM OPTRELL ACCESS AND THE OTHER PART WAS PULLED FROM THE ABBOTT SUPREME QUAD ACCESS. THE PROCEDURE WAS CONTINUED AND COMPLETED. THE CALLER REPORTED THAT NO PIECES OF THE CATHETERS WERE LEFT INSIDE OF THE BODY AND THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ACCORDING TO THE PHYSICIAN, THE CATHETER BEING KINKED INSIDE OF THE SHORT SHEATH WAS BELIEVED TO BE A RISK FOR POTENTIAL HARM OR INJURY TO THE PATIENT. NO INNER PARTS FOR THE CATHETER WERE EXPOSED DUE TO THIS DAMAGE UNTIL THE CATHETERS WERE CUT OUTSIDE OF THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956143 OPTRELL CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31242690M 10846835023015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT SUPREME QUAD CATHETER| NGEN¿ SYSTEM| UNKNOWN SHORT SHEATH