BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-MED CENTRAL VENOUS CATHETER SET WITH AMC THROMBOSHIELD

    MDR report key: 3243675 · Received July 23, 2013

    Report

    Report Number
    2015691-2013-20658
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    FOZ
    PMA / PMN Number
    K955839
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 7F 20CM DOUBLE LUMEN MULTI-MED CATHETER WAS RETURNED WITH A 0.034¿ X 60CM GUIDEWIRE. EXAMINATION OF THE RETURNED GUIDEWIRE FOUND THAT THERE WAS A WELD BREAK ON THE "J" TIP END OF THE WIRE. THE OUTER COIL WIRE HAD BEEN UNCOILED OVER A 15CM AREA OF THE GUIDEWIRE. A NEW LABORATORY SAMPLE GUIDEWIRE WAS PASSED TIP TO HUB AND HUB TO TIP AND THE GUIDEWIRE PASSED FREELY THE ENTIRE LENGTH IN BOTH DIRECTIONS. THERE WERE NO MISSING PARTS OF THE GUIDEWIRE OBSERVED. ALL THROUGH LUMENS WERE PATENT AND DID NOT LEAK. THE CATHETER BODY WAS RETURNED UNDAMAGED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE COMPLAINT OF ¿GUIDEWIRE PARTIALLY RUPTURED¿ WAS CONFIRMED; HOWEVER, THERE ARE NO INDICATIONS THAT THIS IS RELATED TO THE MANUFACTURING PROCESS. ALTHOUGH THE ROOT CAUSE OF THE DAMAGE CANNOT BE CONCLUSIVELY DETERMINED, HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AS STATED IN THE PRODUCT IFU, THE GUIDEWIRE SHOULD NEVER BE FORCED. IF DIFFICULTY IS MET DURING INSERTION OF THE GUIDEWIRE, COMPLETELY WITHDRAW THE GUIDEWIRE AND RE-ATTEMPT INSERTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GUIDEWIRE WAS PARTIALLY RUPTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343305 MULTI-MED CENTRAL VENOUS CATHETER SET WITH AMC THROMBOSHIELD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ EDWARDS LIFESCIENCES, PR M2720HE 59302464

    Patients

    Seq Age Sex Outcome Treatment
    1