BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 3103218 · Received May 9, 2013

    Report

    Report Number
    9673241-2013-00149
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A PROCEDURE IT WAS REPORTED THERE WAS SIGNAL NOISE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT¿S CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS EVENT WAS REPORTED ON (B)(4) 2013. THIS CATHETER WAS RECEIVED ON (B)(4) 2013 FOR FURTHER ANALYSIS. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED. IT WAS FOUND THE CATHETER RING #17 AND RING 19 HAD WHITE RESIDUE. RING # 20 WAS DENT AND HAD RESIDUE. THE CATHETER ANCHOR WINDOW HAD DARK BROWN RESIDUE. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE ANCHOR PIN WAS BROKEN AND HAD BROWN RESIDUE. RING #17 HAD WHITE RESIDUE. RING #19 HAD RESIDUES. RING # 20 WAS DENTED AND HAD RESIDUE. SPINE COVER WAS FOUND WRINKLE AND FATTEN ON PROXIMAL SIDE OF RING # 20. THESE CONDITIONS WERE NOT REPORTED ON THE ORIGINAL COMPLAINT. A FTIR ANALYSIS WAS INTENDED TO BE CONDUCTED HOWEVER DUE TO THE SIZE OF THE RESIDUES IT WAS NOT POSSIBLE THEREFORE THE ORIGIN OF THE RESIDUE REMAINS UNKNOWN. THE CATHETER WAS OBSERVED ON X-RAY AND IT WAS NOTICED THAT THE T-BAR SLID DOWN THE LUMEN. THE T-BAR TEAR OFF CREATES A SPACE WHICH WEAKENED THE ANCHOR WINDOW AREA. THIS CAUSED THE PU TO EITHER PEEL OFF OR CRACK. THE CATHETER WAS ELECTRICALLY TESTED AND IT PASSED SPECIFICATIONS. DURING THE ANALYSIS IT WAS FOUND THAT THE CATHETER COULD NOT BE DEFLECTED DUE TO THE T-BAR CONDITION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IN ADDITION, ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. THE CUSTOMER COMPLAINT ABOUT NOISE CANNOT BE CONFIRMED; HOWEVER DURING THE ANALYSIS A DEFLECTION ISSUE WAS OBSERVED. FOR THE FOREIGN MATERIAL ISSUE, AN INTERNAL CORRECTIVE ACTION HAS BEEN CREATED. ANOTHER INTERNAL CORRECTIVE ACTION WAS CREATED FOR THE T-BAR ISSUE.

    Description of Event or Problem · 1

    DURING A PROCEDURE, IT WAS REPORTED THERE WAS SIGNAL NOISE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT'S CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS EVENT WAS REPORTED ON (B)(4) 2013. THIS CATHETER WAS RECEIVED ON (B)(4) 2013 FOR FURTHER ANALYSIS. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED. IT WAS FOUND THE CATHETER RING #17 AND RING 19 HAD WHITE RESIDUE. RING # 20 WAS DENT AND HAD RESIDUE. THE CATHETER ANCHOR WINDOW HAD DARK BROWN RESIDUE. DUE TO THE CONDITION OF THE CATHETER THIS EVENT IS NOW A MDR REPORTABLE EVENT. ALERT DATE WAS RESET TO (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203454 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15671238L

    Patients

    Seq Age Sex Outcome Treatment
    1