BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2771870 · Received October 4, 2012

    Report

    Report Number
    2029046-2012-00135
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 27, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY. THE CORRECT SUBMISSION DATE FOR THE INITIAL REPORT (MFR. REPORT # 2029046-2012-00125), WAS (B)(4) 2012. (B)(4). UPON RECEIPT, THE RETURNED DEVICE WAS VISUALLY INSPECTED AND WAS OBSERVED THAT THE RING #9 WAS DAMAGED AND HAD SOME WHITE FOREIGN MATERIAL CAUGHT UNDERNEATH WHICH WAS NOT REPORTED IN THE ORIGINAL COMPLAINT. A FT-IR TEST WAS PERFORMED TO IN ORDER TO IDENTIFY THE TYPE OF FOREIGN MATERIAL; THE RESULTS DEMONSTRATED THAT THE PARTICLE IS A POLYETHYLENE POLYMER - BASED MATERIAL. IT IS UNKNOWN HOW THE RING WAS DAMAGED AND THE ORIGIN OF THE FOREIGN MATERIAL. A DIMENSIONAL TEST WAS PERFORMED TO THE RINGS IN ORDER TO DETERMINE IF THE PU MARGINS WHERE WITHIN SPECIFICATIONS. HOWEVER THE CATHETER WAS FOUND WITHIN SPECIFICATIONS. PER THE REPORTED EVENT, THE CATHETER'S FUNCTIONALITIES WERE EVALUATED AND THE DEVICE PASSED DEFLECTION CHARACTERISTICS, ELECTRICAL RESISTANCE AND CURRENT LEAKAGE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS FAILURE MODE. 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. FURTHER INVESTIGATION REGARDING THE FOREIGN MATERIAL FOUND AT BWI FAILURE ANALYSIS LAB THAT WAS NOT REPORTED IN THE COMPLAINT RESULTED IN AN INTERNAL CORRECTIVE ACTION THAT WAS OPENED TO ADDRESS THIS ISSUE. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE INSTRUCTION FOR USE (IFU) RECOMMENDS THAT A CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN AFIB PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. THIS LASSO CATHETER WAS A CONCOMITANT PRODUCT TO THE ADVERSE EVENT THAT HAD BEEN REPORTED PREVIOUSLY UNDER THE ABLATION CATHETER NAVISTAR THERMOCOOL (MFR. REPORT # # 2029046-2012-00125) ON (B)(6) 2011. UPON VISUAL INSPECTION OF THIS RETURNED CONCOMITANT COMPLAINT PRODUCT ON (B)(4) 2012, IT WAS NOTED THAT WHITE RESIDUE WAS STICKING OUT FROM THE PROXIMAL SIDE OF RING # 9. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. THE ELECTRODE RING DAMAGE AND PRESENCE OF FOREIGN MATERIAL UNDER THE RING CONDITION IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(4) 2012 AS THE ALERT DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1220-39-S UNKNOWN_D-1220-39-S

    Patients

    Seq Age Sex Outcome Treatment
    1