BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ADHERENT CLOT CATHETER

    MDR report key: 3130580 · Received May 24, 2013

    Report

    Report Number
    2015691-2013-20166
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    K901625
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE BROKEN CATHETER TUBE WAS RECEIVED IN A CRUSHED OUTER BOX. TWO CATHETERS WERE RECEIVED INSIDE A (B)(4) TRIANGLE BOX, WHICH WAS RECEIVED INSIDE A RECTANGLE CARDBOARD OUTER BOX. BOTH CATHETER TUBES WERE RECEIVED BROKEN. ALSO NOTE THE (B)(4) BOX WAS EXTENDED USING A SECOND (B)(4) BOX THAT WAS CUT IN HALF AND TAPED IN PLACE OVER THE ORIGINAL BOX TO ACCOMMODATE THE LENGTH OF THE CATHETER TUBES. THE (B)(4) BOX HAS BEEN CRUSHED DURING SHIPPING, COLLAPSING THE BOX EXTENSION TO THE POINT THE CATHETER TUBES WILL NOT FIT ANY LONGER. THE WHITE CATHETER SHIPPING TUBE WAS BROKEN AT THE DISTAL EDGE OF THE CLEAR ADAPTOR. THE SHRINK SEALS ARE STILL ATTACHED, ONE AT THE CLEAR ADAPTOR CAP AND THE OTHER AROUND THE IFU. THE CATHETER TUBE WAS REMOVED FROM THE OUTER BOX AND PLACED NEXT TO THE TRIANGULAR OUTER BOX, IT WAS FOUND THAT WHEN THE CATHETER TUBE IS PLACED TO ONE END OF THE OUTER BOX THE BREAK AREA LINED-UP WITH THE DAMAGE ON THE OUTER BOX. THE CATHETER WAS FOUND TO BE IN BENT IN SEVERAL AREAS. THE DAMAGE APPEARS TO BE RELATED TO SHIPPING OF THE PRODUCT. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE COMPLAINT WAS CONFIRMED AND APPEARS TO BE RELATED TO SHIPPING OF THE PRODUCT. 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. THIS REPORT IS ASSOCIATED WITH REPORT 2015691-2013-20167.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 CATHETERS WERE FOUND BROKEN IN HALF BEFORE USE. THE CATHETERS WERE FOUND TO BE BROKEN IN THE STERILE SHIPPING TUBES AT THE TIME OF RECEIVING. IT WAS FURTHER STATED THAT THE "TRIANGLE" SHIPPING BOX WAS NOT A VERY STURDY BOX. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231176 FOGARTY ADHERENT CLOT CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES, PR 140806 59478119

    Patients

    Seq Age Sex Outcome Treatment
    1