BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECANAV ELECTROPHYSIOLOGY CATHETER

    MDR report key: 19388798 · Received May 23, 2024

    Report

    Report Number
    2029046-2024-01695
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 28, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835008807
    PMA / PMN Number
    K080425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 2-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DAMAGE DID NOT RESULT IS EXPOSED WIRES AND NO SHARP RINGS. THERE WAS NO RESISTANCE AND THE CATHETER WAS NOT PRE-SHAPED. THIS WAS NOT AN ISSUE OF THE DEFLECTION NOT HOLDING. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. VISUAL AND DIMENSIONAL INSPECTIONS OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED CORROSION IN THE CONNECTOR PINS AREA. NO OTHER DAMAGE OR ANOMALIES WERE NOTICED IN ANY OTHER PORTION OF THE DEVICE. A DIMENSIONAL INSPECTION WAS PERFORMED, AND THE DEVICE PASSED WITHIN SPECIFICATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTION WERE IDENTIFIED. THE BROKEN TIP ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE POTENTIAL CAUSE OF THE CORROSION CONDITION COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) STATE THAT: CATHETER ADVANCEMENT AND PLACEMENT SHOULD BE DONE UNDER DIRECT IMAGING GUIDANCE (SUCH AS FLUOROSCOPY OR ULTRASOUND). REMOVE THE CATHETER FROM ITS PACKAGE AND PLACE IT IN A STERILE WORK AREA. CREATE A VASCULAR ACCESS IN A LARGE PERIPHERAL VEIN USING ASEPTIC TECHNIQUES AND INSERT A COMPATIBLE CATHETER SHEATH INTRODUCER (AT A MINIMUM SHEATH SHOULD BE HALF A FRENCH SIZE LARGER THAN THE CATHETER FRENCH SIZE). AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: INAPPROPRIATE MATERIAL (C0602)/INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15)/COMPONENT CODE: CONNECTOR/COUPLER (G04034) WERE SELECTED AS RELATED TO THE CORROSION IN THE CONNECTOR PINS AREA IDENTIFIED BY BWI PAL. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19)/INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED BROKEN TIP. 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

    ON 28-MAY-2024, 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 A DECANAV ELECTROPHYSIOLOGY CATHETER AND THE CATHETER TIP WAS SOFT. IT WAS REPORTED THAT DURING THE SURGERY, THE CATHETER TIP WAS FOUND TO BE SOFTER THAN PRODUCT OF THE SAME TYPE, WHICH MADE IT NOT EASY TO PUT IT INTO OSTIUM OF CORONARY SINUS. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATING THERE WAS NO RESISTANCE OR DAMAGE TO THE CATHETER OR SHEATH. THE DILATOR WAS ABLE TO MOVE WITHIN THE SHEATH. THE ACCESS IS PLACED AFTER THE SINUS ORIFICE IS DRAWN UNDER ULTRASOUND, AND THE DECANAV ELECTROPHYSIOLOGY CATHETER EASILY DROPPED AFTER IT IS PLACED IN THE CORONARY SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656643 DECANAV ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31240184M 10846835008807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOW NEEDLE| UNKNOWN SHEATH