BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

    MDR report key: 2122199 · Received June 13, 2011

    Report

    Report Number
    9673241-2011-00062
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED CATHETER WAS DIMENSIONALLY EVALUATED. IT WAS MEASURED AND OD RINGS, PU MARGINS AND TRANSITION SECTION WERE FOUND WITHIN SPECIFICATIONS. VISUAL INSPECTION REVEALED A TWISTED CONDITION IN THE SHAFT AND TWO BENT SECTIONS JUST NEXT TO THE SLEEVING AND IN THE TIP. COMPLAINT WAS CONFIRMED, TWISTED CONDITION APPEARS TO BE CAUSED BY EXCESSIVE FORCE APPLIED DURING THE PROCEDURE. ALL CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING PER PROCEDURE. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. 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.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED THAT THERE WAS A MECHANICAL MALFUNCTION OF THE CATHETER. THE CATHETER WAS TWISTED ON THE SHAFT AFTER EPICARDIAC PLACING. THE PHYSICIAN WAS NOT ABLE TO CONTINUE OR TO PULL THE CATHETER OUT OF THE INTRODUCER. THE CATHETER WAS PULLED OUT FROM EPICARDIAL SPACE WITH A LOOP. NEW INTRODUCER AND CATHETER WERE USED TO CONTINUE THE PROCEDURE. THEY STATED THAT THE PHYSICIAN DID NOT MANEUVER IN ANY UNUSUAL WAY. NO PATIENT INJURY WAS REPORTED. THE INTRODUCER USED WAS NON BWI INTRODUCER (SJM SL-1)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-16-S 15308818M

    Patients

    Seq Age Sex Outcome Treatment
    1