BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER

    MDR report key: 5494180 · Received March 10, 2016

    Report

    Report Number
    9673241-2016-00193
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    March 3, 2016
    Report Date
    March 3, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    MTD
    PMA / PMN Number
    K123837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PENTARAY CATHETER WOULD NOT FULLY RELAX DEFLECTION, THOUGH IT RELAXED PARTIALLY. THEY EXCHANGED THE CATHETER TO CONTINUE THE CASE. REPLACEMENT CATHETER REQUESTED. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. A PRECURVE TEST WAS PERFORMED AND CATHETER WAS FOUND WITHIN SPECIFICATIONS. CATHETER WAS NOT STUCK AT ANY STAGE OF THE TEST; A NORMAL BEHAVIOR WAS OBSERVED. THE DEVICE HISTORY RECORD (DHR) 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 CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17407110L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 03/25/2016. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PENTARAY NAV ECO CATHETER WAS STUCK IN A FULLY DEFLECTED POSITION, BUT WAS ABLE TO BE STRAIGHTENED BY WITHDRAWING INTO THE SHEATH. THERE WAS NO DIFFICULTY REMOVING THE CATHETER. 8.5F MOBICATH STEERABLE SHEATH (D140011) WAS USED DURING PROCEDURE. THE CASE CONTINUED BY CHANGING CATHETER. THIS IS MDR REPORTABLE AS IT COULD POTENTIALLY CAUSE VESSEL DAMAGE OR CARDIAC STRUCTURE DAMAGE DURING FORCEFUL WITHDRAWAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150118 PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER, INC. (JUAREZ) D-1282-08-S 17407110L

    Patients

    Seq Age Sex Outcome Treatment
    1