BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 22091941 · Received May 27, 2025

    Report

    Report Number
    2029046-2025-01708
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    April 30, 2025
    Report Date
    August 11, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025811
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 17-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 AN ISVT (INCESSANT SUPRAVENTRICULAR TACHYCARDIA) CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE DEVICE WAS STUCK IN THE 8.5 FR. TERUMO SHEATH INSIDE THE PATIENT'S FEMORAL ARTERY. IT WAS FOLDED BACK ON ITSELF AND THE PHYSICIAN WAS UNABLE TO RETRACT IT FROM THE PATIENT. THE ISSUE OCCURRED AS THE CATHETER WAS PROLAPSED IN THE LEFT VENTRICLE (LV) INTENTIONALLY. THE MEDICAL TEAM PULLED CATHETER BACK AND WHEN TRYING TO UN-PROLAPSE AND PULLING BACK, IT WAS PULLED BACK TOO FAR AND BECAME STUCK IN THE SHEATH. THE PHYSICIAN CUT THE HANDLE OFF THE CATHETER, EXCHANGED SHEATHS AND THEY WERE ABLE TO UN-PROLAPSE THE CATHETER AND PULL IT BACK INTO THE SHEATH AND REMOVE IT FROM THE PATIENT WITHOUT INJURY. THERE WAS NO INTERNAL PARTS EXPOSED. THERE WERE NO DETACHMENTS OR SHARP EDGES NOTED. THE MEDICAL TEAM OPENED A NEW OPTRELL TO CONTINUE THE CASE SUCCESSFULLY TO COMPLETION. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL AND MICROSCOPICAL INSPECTIONS OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE SHAFT WAS CUT NEAR TO THE HANDLE, IT WAS BENT CLOSE TO THE TIP TRANSITION, THE TIP WAS COVERED WITH REDDISH MATERIAL; HOWEVER, NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE TIP AND SHAFT OF THE DEVICE, AND IT WAS FOUND WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31442202M, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. BASED ON THE DAMAGE OBSERVED THE EVENT DESCRIBED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ENTRAPMENT ISSUE COULD BE RELATED TO THE PROCEDURE AS IT IS STATED IN THE EVENT INFORMATION THAT A 9 FR SHEATH INSTEAD OF 8.5 FR WAS USED ALONG WITH THIS CATHETER WHICH CONTRADICTS THE INSTRUCTION FOR USE AND RECOMMENDATIONS OF THIS DEVICE; HOWEVER, THIS COULD NOT BE ESTABLISHED CONCLUSIVELY. THE POTENTIAL CAUSE OF THE FOREIGN REDDISH MATERIAL ATTACHED TO THE TIP COULD BE RELATED TO THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE POTENTIAL CAUSE OF THE SHAFT BENT AND CUT COULD BE A CONSEQUENCE OF THE ENTRAPMENT ISSUE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: THE CATHETER IS RECOMMENDED FOR USE WITH AN 8.5 F GUIDING SHEATH BECAUSE THE SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE. TO AVOID ENTANGLEMENT OR ENTRAPMENT WHICH MAY RESULT IN THE NEED FOR SURGICAL INTERVENTION, EXERCISE CAUTION WHEN MANEUVERING THE CATHETER NEAR THE VALVULAR APPARATUS AND OTHER DEVICES. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH IF RESISTANCE IS ENCOUNTERED. PRIOR TO REMOVING OR REPOSITIONING THE CATHETER, USE DIRECT IMAGING GUIDANCE SUCH AS FLUOROSCOPY OR ULTRASOUND TO CONFIRM THAT THE SPINE ASSEMBLY IS NOT ENTANGLED WITH ANOTHER CATHETER OR WITH AN ANATOMICAL STRUCTURE. ALWAYS PLACE THE ROCKER LEVER IN THE NEUTRAL POSITION TO STRAIGHTEN THE CATHETER TIP BEFORE INSERTION OR WITHDRAWAL OF THE CATHETER. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH 'S 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 AN ISVT CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE DEVICE WAS STUCK IN THE 8.5 FR. TERUMO SHEATH INSIDE THE PATIENT'S FEMORAL ARTERY. IT WAS FOLDED BACK ON ITSELF AND THE PHYSICIAN WAS UNABLE TO RETRACT IT FROM THE PATIENT. THE ISSUE OCCURRED AS THE CATHETER WAS PROLAPSED IN THE LEFT VENTRICLE (LV) INTENTIONALLY. THE MEDICAL TEAM PULLED CATHETER BACK AND WHEN TRYING TO UN-PROLAPSE AND PULLING BACK, IT WAS PULLED BACK TOO FAR AND BECAME STUCK IN THE SHEATH. THE PHYSICIAN CUT THE HANDLE OFF THE CATHETER, EXCHANGED SHEATHS AND THEY WERE ABLE TO UN-PROLAPSE THE CATHETER AND PULL IT BACK INTO THE SHEATH AND REMOVE IT FROM THE PATIENT WITHOUT INJURY. THERE WAS NO INTERNAL PARTS EXPOSED. THERE WERE NO DETACHMENTS OR SHARP EDGES NOTED. THE MEDICAL TEAM OPENED A NEW OPTRELL TO CONTINUE THE CASE SUCCESSFULLY TO COMPLETION. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715195 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31442202M 10846835025811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TERUMO, 8.5 FR. SHEATH