BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 19251414 · Received May 6, 2024

    Report

    Report Number
    2029046-2024-01480
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 11, 2024
    Report Date
    August 22, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835023015
    PMA / PMN Number
    K211438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    ON 15-MAY-2024, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31107132M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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

    NOTE: D4 PRIMARY UDI NUMBER HAS BEEN UPDATED TO (B)(4). ON 28-JUL-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE ATRIAL CONTRACTION CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IT COULD NOT ADVANCE THROUGH THE SHEATH. THE PHYSICIAN DESCRIBED THE HEAD OF THE OPTRELL AS "MANGLED" AFTER REMOVING IT FROM THE SHEATH. THERE WERE NO EXPOSED WIRES OR SHARP PORTIONS NOTED. THE PHYSICIAN WAS UNABLE TO DETERMINE IF THE OPTRELL WAS DAMAGED PRIOR TO ENTERING THE SHEATH. THE OPTRELL CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED BENT SPLINES AT THE TIP OF THE DEVICE, NO LIFTED ELECTRODES OR WIRES EXPOSED WERE FOUND. A DIMENSIONAL TEST WAS PERFORMED, AND OUTER DIAMETERS OF THE DEVICE WERE FOUND WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31107132M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE RESISTANCE ISSUE AND BROKEN TIP REPORTED BY THE CUSTOMER COULD BE RELATED TO THE BENT SPLINES OBSERVED DURING THE ANALYSIS; THEREFORE, THE COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THIS ISSUE COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH IF RESISTANCE IS ENCOUNTERED. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE QUALITY SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE ATRIAL CONTRACTION CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IT COULD NOT ADVANCE THROUGH THE SHEATH. THE PHYSICIAN DESCRIBED THE HEAD OF THE OPTRELL AS "MANGLED" AFTER REMOVING IT FROM THE SHEATH. THERE WERE NO EXPOSED WIRES OR SHARP PORTIONS NOTED. THE PHYSICIAN WAS UNABLE TO DETERMINE IF THE OPTRELL WAS DAMAGED PRIOR TO ENTERING THE SHEATH. THE OPTRELL CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576866 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31107132M 10846835023015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN GENERATOR.