BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 3143429 · Received June 3, 2013

    Report

    Report Number
    2015691-2013-20231
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED IN A BROKEN SHIPPING TUBE. THE GRAY SHIPPING TUBE WAS BROKEN 41CM PROXIMAL OF THE BOTTOM END OF THE GRAY TUBE. THE BALLOON, WINDINGS AND CATHETER BODY TUBE WERE FOUND TO BE IN GOOD CONDITION. THE OUTER CARDBOARD BOX HAS BEEN CRUSHED IN SEVERAL AREAS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. AN INVESTIGATION WAS OPENED TO DETERMINE THE VARIABLES THAT CAN IMPACT THE PRODUCT DURING SHIPPING, IN AN EFFORT TO REDUCE COMPLAINTS OF THIS TYPE. THE ROOT CAUSE INVESTIGATION WAS COMPLETED BY A CROSS-FUNCTION TEAM COMPRISING OF REPRESENTATIVES FROM PACKAGING ENGINEERING, QUALITY, MARKETING AND LOGISTICS. THE TEAM INVESTIGATED THE ISSUE AND IDENTIFIED THE MOST PROBABLY ROOT CAUSE AS PACKAGES ARE BEING DAMAGED WHILE TRAVELING ON THE CONVEYOR SYSTEM AT THE CARRIER SORTING FACILITY. THE RESULTING CORRECTIVE ACTION PLAN FROM THIS ROOT CAUSE INVESTIGATION YIELDED THE FOLLOWING ACTIONS ITEMS: . IMPLEMENT A HEAVY DUTY CYLINDER WITH AND ADJUSTABLE TUBE OF 0.18" (THICKNESS) USED FOR SHIPPING PURPOSES. COMMUNICATE TO THE EDWARD DISTRIBUTION CHANNELS THE REQUIREMENT FOR THE USE OF THE HEAVY DUTY CYLINDER USAGE FOR SHIPPING PURPOSES. ESTABLISH A CONTRACTUAL REQUIREMENT WITH EDWARDS DISTRIBUTION CHANNELS TO USE THE HEAVY DUTY CYLINDER FOR SHIPPING PURPOSES.

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THE CATHETER WAS DISCARDED. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT A PRODUCT RETURN; HOWEVER, OTHER COMPLAINTS OF THIS TYPE HAVE BEEN CONFIRMED. AN INVESTIGATION IS CURRENTLY UNDERWAY TO DETERMINE THE VARIABLES THAT CAN IMPACT THE PRODUCT DURING SHIPPING, IN AN EFFORT TO REDUCE COMPLAINTS OF THIS TYPE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Additional Manufacturer Narrative · 1

    THE CATHETER IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. THIS REPORT IS ASSOCIATED WITH REPORT # 2015691-2013-20230.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO CATHETERS WERE RECEIVED DAMAGED, THE SHIPPING TUBES WERE BROKEN. THE OUTER BOX APPEARED FOLDED IN THE MIDDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243988 FOGARTY ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES, PR 120806F 59446150

    Patients

    Seq Age Sex Outcome Treatment
    1