BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 2882802 · Received December 20, 2012

    Report

    Report Number
    2015691-2012-18913
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 3, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE FOGARTY ARTERIAL EMBOLECTOMY WAS RECEIVED, THE INFLATION SYRINGE WAS NOT RETURNED WITH THE CATHETER. THE BALLOON LATEX AND WINDINGS APPEARED INTACT. THERE WAS NO VISIBLE DAMAGE OBSERVED FROM THE CATHETER BODY. BALLOON WAS INFLATED WITH 0.2CC AIR WITH A LABORATORY SAMPLE SYRINGE. BALLOON INFLATED CLEARLY AND CONCENTRICALLY. THE BALLOON DEFLATED WITHIN 1 SECOND WITHOUT THE SYRINGE ATTACHED. BALLOON DEFLATION WAS ACHIEVED WITHIN ALLOWABLE SPECIFICATION. THE BALLOON WAS DEFLATED BY REMOVING THE SYRINGE. THE REPORTED DEFECT WAS NOT CONFIRMED, AND THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. IT COULD NOT BE DETERMINED IF SOME PROCEDURAL OR CLINICAL FACTORS CONTRIBUTED TO THE DEFLATION DIFFICULTY REPORTED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    PRIOR TO USE IN THE PATIENT, THE BALLOON WAS TESTED AND IT INFLATED AND DEFLATED WITHOUT INCIDENT. WHILE INSIDE THE PATIENT, THE BALLOON INITIALLY INFLATED WITHOUT A PROBLEM BUT AT SOME POINT "WHILE IN THE BRAIN, THE SURGEON HAD DIFFICULTY DEFLATING THE BALLOON AND HAD TO SPEND SEVERAL MINUTES ATTEMPTING TO DEFLATE THE BALLOON. HE WAS SUCCESSFUL AFTER MULTIPLE ATTEMPTS TO DEFLATE. FOLLOWING REMOVAL FROM THE PATIENT, THE SURGEON TESTED THE BALLOON AGAIN AND IT INFLATED BUT IT COULD NOT BE DEFLATED. AT THIS TIME, THE CONSEQUENCES ARE UNKNOWN BUT THE PATIENT HAS BEEN CLOSELY WATCHED FROM A NEUROLOGICAL PERSPECTIVE."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THEY REPORTED THAT THE INFLATION MEDIUM USED FOR THE BALLOON CATHETER WAS "50,000U BACITRACIN/LITER OF PLASMALYTE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES, PR 120602F 59224386

    Patients

    Seq Age Sex Outcome Treatment
    1