BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER

    MDR report key: 6274901 · Received January 24, 2017

    Report

    Report Number
    9673241-2017-00071
    Event Type
    Malfunction
    Date Received
    January 24, 2017
    Date of Event
    December 2, 2016
    Report Date
    December 2, 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 Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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. CONCOMITANT PRODUCTS: SMART TOUCH CATHETER, MODEL # D-1327-05-S, LOT # 17580572M. SMART TOUCH CATHETER, MODEL # D-1327-05-S, LOT # 17553109M. SMARTABLATE GENERATOR. CARTO 3 SYSTEM. ST. JUDE MEDICAL AGILIS 8.5FR SHEATH. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A PENTARAY NAV ECO CATHETER WHERE THE SPINES BECAME BENT. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND TWO SPINES WERE FOUND FOLDED BACK. ADDITIONALLY, SOME ELECTRODES WERE FOUND DAMAGED, WITH LIFTED AND SHARP RINGS. PER THIS CONDITION, THE CATHETER OUTER DIAMETERS WERE MEASURED AND WERE FOUND WITHIN SPECIFICATIONS. THE POLYURETHANE MARGINS WERE FOUND TO BE PROPERLY APPLIED. DURING THE MANUFACTURING PROCESS, ALL CATHETERS ARE INSPECTED FOR VISUAL DAMAGE PRIOR TO PACKAGING. 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 HAS BEEN VERIFIED. HOWEVER, THE ROOT CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS. BASED ON THE AVAILABLE ANALYSIS FINDING AND RESULTS, THE FAILURE MODE DOES NOT APPEAR TO BE CAUSED BY ANY INTERNAL BWI PROCESSES. THERE IS EVIDENCE THAT THE MANUFACTURING PROCESS WAS FOLLOWED PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A PENTARAY NAV ECO CATHETER WHERE THE SPINES BECAME BENT. HALFWAY THROUGH THE PROCEDURE, IT WAS FOUND THAT THE SPINES ON THE PENTARAY CATHETER HAD LOST THEIR SHAPE. THERE WERE MINOR BENDS REPORTED, BUT NO WIRES WERE EXPOSED. NO DIFFICULTY WAS REPORTED WITH REMOVING THE CATHETER, BUT THERE WAS SOME DIFFICULTY INSERTING IT. THE PENTARAY CATHETER WAS REPLACED, AND THE CASE CONTINUED WITHOUT ANY REPORT OF PATIENT CONSEQUENCE. ON (B)(6) 2017, THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB FOUND THAT THE TOP RING ON THE CATHETER WAS FOLDED BACK AND LIFTED WITH A SHARP EDGE. ADDITIONALLY, THE SECOND RING WAS SMASHED, CREATING SHARP EDGES ON THE SIDES. THE DAMAGE WAS NOT NOTED PRIOR TO USE OF THE CATHETER, UPON WITHDRAWAL, OR PRIOR TO SENDING THE CATHETER BACK. THE SHEATH IN USE WAS A ST. JUDE MEDICAL AGILIS 8.5FR. IF ELECTRODE RING EDGES ARE SHARP OR ROUGH, THEY CAN CAUSE DAMAGE TO VASCULAR ENDOTHELIAL LININGS DURING WITHDRAWAL OF THE CATHETER/SHEATH. AS A RESULT, THIS EVENT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55143 PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER, INC. (JUAREZ) D-1282-11-S 17593054L

    Patients

    Seq Age Sex Outcome Treatment
    1