BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3171082 · Received June 14, 2013

    Report

    Report Number
    9673241-2013-00193
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE THAT THE LASSO NAV VARIABLE ECO CATHETER LOOP WAS NOT CLOSING TIGHTLY ENOUGH. THIS CATHETER WAS REPLACED AND THE CASE WAS CONTINUED. THERE WAS NO PATIENT INJURY REPORTED. THE INITIAL REPORTED COMPLAINT ITSELF WAS NOT INDICATIVE OF A REPORTABLE EVENT BECAUSE THE COMPLAINT ISSUE WAS HIGHLY DETECTABLE WITHOUT ANY PATIENT CONSEQUENCE. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON (B)(4) 2013, THE BWI FAILURE ANALYSIS LAB NOTED THAT ELECTRODE RING #1 WAS DENTED; ELECTRODE RING #2 WAS SQUASHED AND SHARP ON THE PROXIMAL SIDE; ELECTRODE RING#3 WAS SQUASHED AND ROUGH ON DISTAL SIDE AND THE PROXIMAL SIDE WAS SHARP; AND ELECTRODE RING #4 WAS SQUASHED AND THE PROXIMAL SIDE WAS SHARP. ADDITIONAL CLARIFICATION WAS REQUESTED ON THIS RETURNED CATHETER CONDITION, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE ELECTRODE RING DAMAGE CONDITION IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(4) 2013 AS THE ALERT DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271655 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 15833785L

    Patients

    Seq Age Sex Outcome Treatment
    1