BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3081311 · Received April 26, 2013

    Report

    Report Number
    9673241-2013-00136
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 4, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE PRODUCT ANALYSIS INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CONFIRMED A PERFORATION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS SENT TO OBSERVATION. THE LASSO CATHETER WAS RECEIVED IN THE LABORATORY FOR ANALYSIS AND IT WAS FOUND THAT THE PROXIMAL SIDE OF THE ELECTRODE RING # 19 WAS DAMAGED. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE ELECTRODE RING # 19 WAS DAMAGED LEAVING THE LEAD WIRE EXPOSED. THIS CONDITION WAS NOT REPORTED IN THE ORIGINAL COMPLAINT. THE PU OUTER DIAMETERS WERE MEASURED AND THEY WERE FOUND WITHIN SPECIFICATION. THEN PER THE EVENT, THE CATHETER WAS ELECTRICALLY TESTED AND IT PASSED SPECIFICATIONS. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION AND THE RING DAMAGE REMAINS UNKNOWN. 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. AN INTERNAL CORRECTIVE ACTION WAS OPENED TO ADDRESS THE RING DAMAGE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CONFIRMED A PERFORATION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS SENT TO OBSERVATION. THIS ADVERSE EVENT WAS REPORTED UNDER THE ABLATION CATHETER REPORT #: 9673241-2013-00128. ON (B)(6) 2013, THE LASSO CATHETER WAS RECEIVED IN THE LABORATORY FOR ANALYSIS AND IT WAS FOUND THAT THE PROXIMAL SIDE OF THE ELECTRODE RING # 19 WAS DAMAGED. BASED ON THE LAB FINDINGS REGARDING THE CATHETER CONDITION RECEIVED, IT WAS DECIDED TO REPORT THIS EVENT DATING THE ALERT DATE AS (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181052 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S UNKNOWN_D-1343-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1