BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER CELSIUS DS DIAGNOSTIC ABLATION DEFLECTABLE 8MM TIP CATHETER

    MDR report key: 992281 · Received February 7, 2008

    Report

    Report Number
    9673241-2008-00008
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    October 9, 2007
    Report Date
    December 10, 2007
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P010068
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED ON 01/08/08. DURING THE EVALUATION, IT WAS NOTICED THAT THE PEEK HOUSING WAS CUT AND SEPARATED, BUT STILL ATTACHED BY THE SAFETY WIRE AND LEAD WIRES. BASED ON THIS FINDING THE COMPLAINT WAS DETERMINED TO BE A REPORTABLE MALFUNCTION. IT IS UNKNOWN HOW THE DAMAGE OF THE CATHETER OCCURRED. TEN SAMPLES FROM THE SAME PART NUMBER WERE OBTAINED FROM FINISHED GOODS INVENTORY (FGI) TO VERIFY THE STRENGTH OF THE PEEK HOUSINGS. THERE WERE NO CATHETERS FROM THE LOT NUMBER INVOLVED IN THIS COMPLAINT AVAILABLE IN FGI, THEREFORE RANDOM SAMPLES WITH DIFFERENT LOT NUMBERS WERE OBTAINED FOR TESTING. THE TEN SAMPLES WERE VISUALLY INSPECTED TO VERIFY THAT THE PEEK HOUSING DID NOT HAVE ANY TYPE OF DAMAGE. ALL SAMPLES PASSED THE VISUAL INSPECTION. FIVE OF THE TEN SAMPLES WERE TORQUE-TESTED AND PASSED THE TORQUE TEST. NONE OF THE PEEKS SHOWED EVIDENCE OF ANY TYPE OF DAMAGE AFTER BEING TORQUED. IN ADDITION, A TENSILE TEST WAS PERFORMED ON ALL 10 SAMPLES OBTAINED FROM FGI AND ALL THE SAMPLES PASSED. AFTER THE ANALYSIS WAS COMPLETED, IT IS STILL UNKNOWN HOW THE FAILURE OCCURRED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND IT WAS FOUND THAT ONE CATHETER WAS SCRAPPED FOR SPLIT PEEK HOUSING. HOWEVER, THE SPLIT PEEK HOUSING SCRAP FOUND IN THE DHR WAS NOT RELATED TO THE COMPLAINT. THE SPLIT PEEK HOUSING SCRAP FOUND IN THE DHR REFERS TO A BREAKAGE ON THE LENGTH (LONGITUDINAL SIDE) OF THE PEEK HOUSING AND NOT HORIZONTAL BREAKAGE AS PRESENTED IN THE COMPLAINT SAMPLE. THE MANUFACTURING ASSOCIATES WERE MADE AWARE OF THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A CELSIUS DS CATHETER "BROKE". THE CATHETER WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION FOUND THAT THE TIP OF THE CATHETER WAS DAMAGED. SUBSEQUENT FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS COMPLAINT. CUSTOMER STATED THAT NO RESISTANCE WAS EXPERIENCED DURING INSERTION OR WITHDRAWAL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CELSIUS DS DIAGNOSTIC ABLATION DEFLECTABLE 8MM TIP CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1194-22-S 13247673

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK