BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 1193113 · Received October 6, 2008

    Report

    Report Number
    2030404-2008-00012
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    IRVINE BIOMEDICAL, INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT CONSEQUENCES WERE REPORTED. ONE USED CATHETER WAS RECEIVED ON 09/26/2008. THE UNIT WAS VISUALLY AND FUNCTIONALLY EXAMINED. RESULTS OF THE TESTING ARE AS FOLLOWS: VISUAL INSPECTION FOUND CATHETER SHAFT DAMAGE AT THE DISTAL FUSE AREA 9.2 CM FROM THE DISTAL TIP. THE CATHETER WAS HELD TOGETHER BY THE INTERNAL COMPONENTS AS DESIGNED. CATHETERS FROM THE SAME LOT WERE PULLED FROM FINISHED GOODS INVENTORY AND WORST CASE CONDITIONS WERE SIMULATED. THE CATHETERS WERE PRECONDITIONED FOR 4 HOURS IN A HEATED 37 DEGREE C WATER BATH (BODY TEMPERATURE), SUBJECTED TO REPETITIVE CYCLES OF FLEXION/DEFLECTION (40 CYCLES STEERING) FOLLOWED BY 720 DEGREE TWISTING FORCE (TORQUE) BASED ON THE SAME ACCEPTANCE CRITERIA ESTABLISHED DURING PRODUCT DESIGN. WITH EACH ROTATION, THE FUSE AREA WAS EXAMINED UNDER A MICROSCOPE. EVIDENCE OF STRESS BUILDUP WAS OBSERVED DURING THE SIMULATION TESTING, HOWEVER, ALL FOUR CATHETERS RETAINED MECHANICAL INTEGRITY AT GREATER THAN 2X THE ACCEPTANCE CRITERIA. THE TEST WAS CONTINUED TO FAILURE. THE FAILURE MODE WAS ONLY DUPLICATED AFTER 4 FULL ROTATIONS IN THE SAME DIRECTION WHICH IS BEYOND NORMAL USE. THE FUSING PROCESS IS CLOSELY MONITORED. PROCESS MONITORING DATA WAS REVIEWED FOR THE PERIOD OF MANUFACTURE OF THIS LOT AS WELL AS A 6 MONTHS PERIOD AND EXCEEDS MINIMUM TENSILE STRENGTH REQUIREMENTS OF 3.37 LBS PER ISO 10555-1. IN ALL CASES, THE CATHETER SHAFT STRETCHED BEFORE A FUSE JOINT FAILURE OCCURRED, INDICATING A STRONG FUSE JOINT. DEVICE HISTORY RECORD FOR LOT 61557 WAS ALSO REVIEWED TO ENSURE ALL MANUFACTURING AND INSPECTION PROCEDURES WERE PERFORMED AND REPORTED AS COMPLETE AND ACCEPTABLE. NO EVIDENCE OF A MANUFACTURING ERROR COULD BE FOUND. IN 2007 AND 2008 COMPLAINTS WERE REVIEWED. THIS IS A RARE OCCURRENCE. THE TEST DATA SUGGESTS THAT THE CATHETER WAS OVER-TORQUED BEYOND NORMAL USE. SINCE LOAD OR TENSION MUST BE PLACED ONTO THE CATHETER, THE DISTAL SECTION MAY HAVE BEEN ENTRAPPED IN A POCKET OF TISSUE. THE FUSING PROCESS AND TUBING TENSILE STRENGTH HAVE BEEN VALIDATED TO ENSURE MECHANICAL INTEGRITY UNDER NORMAL USE CONDITIONS. THE INSTRUCTION FOR USE STATE "EXCESSIVE BENDING OR KINKING OF THE CATHETER MAY CAUSE DAMAGE TO THE CATHETER."

    Description of Event or Problem · 1

    DAMAGE TO THE DISTAL SECTION OF THE CATHETER SHAFT WAS REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY ABLATION CATHETER ABLATION CATHETER LPB IRVINE BIOMEDICAL, INC. 83382 61557

    Patients

    Seq Age Sex Outcome Treatment
    1