BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3010461 · Received March 19, 2013

    Report

    Report Number
    9673241-2013-00070
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED. IT WAS OBSERVED THAT RING #10 WAS DAMAGED AND HAD WHITE RESIDUES. A FT-IR TEST WAS PERFORMED IN ORDER TO IDENTIFY THE TYPE OF FOREIGN MATERIAL; HOWEVER THE SAMPLE RESIDUAL SIZE WAS TOO SMALL AND ANALYSIS COULD NOT BE CONCLUDED. IT WAS UNKNOWN HOW THE RING WAS DAMAGED AND THE ORIGIN OF THE FOREIGN MATERIAL. THE PU RINGS ODS WERE MEASURED AND CATHETER WAS WITHIN SPECIFICATIONS. AN INTERNAL CORRECTIVE ACTION HAS BEEN CREATED TO INVESTIGATE THE DAMAGED RING ISSUE. THE RETURNED DEVICE WAS EVALUATED FOR ELECTRICAL RESISTANCE AND CURRENT LEAKAGE AND IT FAILED ON ELECTRODES #2, #6 AND #8. FURTHER EXAMINATION REVEALED THAT THE LEAD WIRES WERE NOT SOLDERED AND WERE SHORTING INSIDE THE CATHETER. 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. THE REPORTED CUSTOMER COMPLAINT HAS BEEN VERIFIED. FOR THE DAMAGE RING ISSUE, AN INTERNAL CORRECTIVE ACTION HAS BEEN CREATED.

    Description of Event or Problem · 1

    DURING THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THE LASSO CATHETER DID NOT HAVE SIGNAL. ISSUE WAS RESOLVED AFTER THE CATHETER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT'S CONSEQUENCE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED. IT WAS OBSERVED THAT RING #10 WAS DAMAGED AND HAD WHITE RESIDUES. DUE TO THE DAMAGED RING AND WHITE RESIDUE, THIS EVENT IS NOW A REPORTABLE EVENT. THIS CONDITION WAS NOT ORIGINALLY REPORTED IN THE CUSTOMER'S COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113673 LASSO¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1220-38-S 15681406L

    Patients

    Seq Age Sex Outcome Treatment
    1