BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 17808845 · Received September 25, 2023

    Report

    Report Number
    2029046-2023-02161
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 31, 2023
    Report Date
    October 25, 2023
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3-OCT-2023, 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. ADDITIONALLY, THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED. 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

    IT WAS REPORTED THAT A PATIENT WITH DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND WHEN TAKING THE CATHETER OUT OF THE BODY RESISTANCE WAS MET. IT WAS REPORTED THAT WHEN TAKING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER OUT OF THE BODY, HE WAS MEETING SOME RESISTANCE AT THE INFERIOR VENA CAVA (IVC) LEVEL ON CARTO WHEN REMOVING THE CATHETER, HOWEVER, HE ELECTED TO ADVANCE AND THEN WAS ABLE TO WITHDRAW AFTER A COUPLE OF TIMES ADVANCING TO THE SUPERIOR VENA CAVA (SVC) VIA CATHETER VISUALIZATION ON THE CATHETER. THE CATHETER WAS MOVED SUPERIOR TO INFERIORLY SEVERAL TIMES AND THE CATHETER WAS ABLE TO BE WITHDRAWN FROM THE BODY. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. VISUAL INSPECTION, DEFLECTION, AND OUTER DIAMETER (OD) TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. A DEFLECTION TEST WAS PERFORMED, AND THE CURVE WAS DEFLECTING WITHIN SPECIFICATIONS. NO DEFLECTION ISSUES WERE OBSERVED. OUTER DIAMETER TEST WAS PERFORMED AND MEASUREMENTS ARE WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. AS PART OF BIOSENSE WEBSTER¿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. 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 WITH DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND WHEN TAKING THE CATHETER OUT OF THE BODY RESISTANCE WAS MET. IT WAS REPORTED THAT WHEN TAKING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER OUT OF THE BODY, HE WAS MEETING SOME RESISTANCE AT THE INFERIOR VENA CAVA (IVC) LEVEL ON CARTO WHEN REMOVING THE CATHETER, HOWEVER, HE ELECTED TO ADVANCE AND THEN WAS ABLE TO WITHDRAW AFTER A COUPLE OF TIMES ADVANCING TO THE SUPERIOR VENA CAVA (SVC) VIA CATHETER VISUALIZATION ON THE CATHETER. THE CATHETER WAS MOVED SUPERIOR TO INFERIORLY SEVERAL TIMES AND THE CATHETER WAS ABLE TO BE WITHDRAWN FROM THE BODY. THEN IMPLANTED AICD WAS THEN INTERROGATED AND THE ATRIAL LEAD WOULD NOT PACE. THE HEART WAS THEN X-RAYED AND THE ATRIAL LEAD WAS DISLODGED. THE PATIENT IS STABLE. A LEAD REVISION IS BEING SCHEDULED. THE PHYSICIAN DISCHARGED THE PATIENT THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881259 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31070528M 10846835023015

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male 8.5F SHEATH WITH CURVE VIZ MDC| SOUNDSTAR ECO SMS 10F CATHETER| THMCL SMTCH SF BID, TC, D-F