BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II SYSTEM

    MDR report key: 289527 · Received August 11, 2000

    Report

    Report Number
    MW4002831
    Event Type
    Injury
    Date Received
    August 11, 2000
    Date of Event
    June 1, 2000
    Report Date
    August 3, 2000
    Manufacturer
    SIMS DELTEC
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    L-BREAST CANCER DIAGNOSED AND LUMPECTOMY AND NODE SURGERY PERFORMED. WAS TOLD BY BREAST SURGEON "FREE AND CLEAR/NO RESTRICTIONS AND ONLY MAYBE TWO WEEKS RADIATION. SAW ONCOLOGIST AND RECOMMENDATIONF FOR 4 ROUNDS CHEMO AT 2 KINDS AND 7 WK OF RADIATION AT 5 DAYS WK AND PILL FOR 5 YRS DUE TO FAMILY HISTORY AND REPEATS. (?) NO BREAST EXAM DONE: RECOMMENDATION ACCEPTED AND BEGAN. WAS TOLD DUE TO HIGHLY TOXIC CHEMO AND NOT ABLE TO CHANGE "ONE DROP" ENTERING SYSTEM. MUST HAVE PORT-A-CATH. POC IMPLANTED AND CHEMO BEGAN 4/12/00. INITIAL PAIN VERY BAD - EXPLANATION OF RECENT SURGERY MADE SENSE. PAIN CONTINUED AND INTESIFIED WORSE AND WORSE. WAS TOLD TO "TAKE MORE PAIN PILLS" AND "SLEEPING PILLS". PAIN CAUSED PHYSICAL COLLAPSE TO THE GROUND FLOOR SEVERAL TIMES. ANTIBIOTICS GIVEN - 2 KINDS/2X'S ON 5/30/00. PT SAID NO MORE. CAN'T TAKE THIS PAIN ANYMORE - IT'S SPREADING - "GET THIS THING OUT OF ME". ONLY HAVE ONE MORE ROUND. PLEASE - IT HURTS." EXAM BY 2 NURSES - WAS SENT TO RADIOLOGY FOR X-RAY W/INJECTION OF DYE AND LARGE (1") SLIT FOUND 3" FROM PORT/ALSO A PROBLEM AT END OF POC/NOTED IN RADIOLOGY REPORT. SENT TO SURGERY CLINIC TO SET UP SURGERY. SURGERY PERFORMED. PT REQUESTED TO SEE DEVICE. AFTER SURGERY TOLD TO REST. ADMIN REFUSED REQUEST, DUE TO THERE INVESTIGATION AND HIGH TOXIDITY OF POC REMOVED. WAS TOLD POC WOULD REMAIN ON PREMISE UNTIL COMPLETION OF HOSP INVESTIGATION. PT WANTED PROOF THIS HAD, IN FACT, BEEN REPORTED TO THE MFR TO BE SURE THIS WAS NOT HAPPENING TO ANOTHER PERSON (OR PERSONS). REQUEST HAS BEEN COMPLETELY IGNORED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 11/1/00: RPTR IN SUCH PAIN AND NO LONGER HAS A SENSE OF SMELL, TASTE (WELL, ALMOST EVERY FEW DAYS, SORT OF, BUT RPTR THINKS IT'S MIND SET TRYING TO TASTE/SMELL SOMETHING), RPTR CAN'T USE RIGHT ARM STRAIGHT OUT OR FOR ANY WEIGHT AT ALL, IT HURTS TO EVEN TOUCH CHEST AREA WHERE THIS PORT IS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 09/28/00: WAS ABLE TO TALK TO A DR AT THE BRISTOL-MYERS SQUIBB CO REGARDING CHEMO LEAK. THEY WERE NOT COOPERATIVE BUT BEGAN TO SEE THAT RPTR IS SERIOUS WHEN THEY TELL THEM ONCOLOGIST WILL NOT HELP. RPTR IS STARTING TO "CRACKLE" INSIDE LIKE WADDING UP SARAN WRAP. HEADACHES ARE BEYOND HORRID AND THAT AREA OF BODY AND ALL OF THE AREA IS PAINFUL. RPTR IS FUNCTIONAL, IN THAT THEY CAN WALK, DRIVE, GET MATERIAL LINED UP AND ALWAYS SMILE, BUT RPTR CAN ONLY HOLD UP IN 4 (+-) HR SEGMENTS. RPTR CAN'T GET A LAWYER, NOBODY WILL HELP. HOWEVER, THE VAST MAJORITY OF THE DRS, NURSES AND STAFF ARE NOT INCLUDED. MFR IS UNABLE TO "CONFIRM OR DENY ALLEGATION THAT THE PRODUCT WAS "DEFECTIVE" AS THE PRODUCT HAS NOT BEEN RETURNED TO SIMS DELTEC, INC FOR EVALUATION. MFR WOULD, HOWEVER, LIKE TO CONDUCT A THOROUGH INVESTIGATION.

    Description of Event or Problem · 1

    PT RECEIVING INDIGENT CARE FOR INFLAMMATORY BREAST CANCER. PORT-A-CATH DEVELOPED LEAK, DOCUMENTED ON X-RAY: 3 INCHES FROM PORT AND 1 INCH LONG. DESPITE COMPLAINTS OF PAIN, THE DEVICE WAS USED FOR 3 FULL DOSES OF CHEMOTHERAPY. PT DEVELOPED SIGNIFICANT PAIN, NECROSIS, AND NOW HAS SENSE OF "SARAN WRAP CRINKLING" IN SHOULDER. AT THE TIME OF THE EVENT PT REQUESTED THE HOSP TO NOTIFY THE MFR ABOUT THE PROBLEM. THE HOSP STAFF REFUSED, AND TOLD PT THAT PT SHOULD REPORT IT. SUBSEQUENT TO PT REQUEST TO REPORT TO THE MFR THE HOSP "COULD NOT FIND" PT'S MEDICAL RECORDS FOR THREE MONTHS. PT MOST RECENTLY INFORMED BY HOSP THAT PT DOES NOT HAVE "INFLAMMATORY BREAST CANCER, JUST THE REGULAR KIND."

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 11/6/00: CO HAS ONE OTHER LEAKAGE COMPLAINT. CO STOPPED SELLING THIS MODEL IN 1995.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 11/7/00: RPTR IS NEEDING SOME KIND OF PHYSICAL PROTECTION AND INTERVENTION FOR THE CARE OF BREAST CANCER AND CHEMOTHERAPY (HIGHLY TOXIC) TRUG LEAK. ALSO, RPTR NEEDS AN IMMEDIATE CAT SCAN OF CURRENT PORT-A-CATH AND ALSO AN OVERDUE (ORDERED BY PRIMARY DR) CAT SCAN W/CONTRAST OF BRAIN. ALSO, IMMEDIATE SURGERY TO REMOVE 2ND "PORT-A-CATH", AND A COMPETANT, HONEST ASSESSMENT OF THE STATUS OF BREAST CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH II SYSTEM IMPLANTED PORT AND CENTRAL LINE CATHETER LJT SIMS DELTEC 21-4003 28208

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R 2) CYCLOPHOSPHAMIDE.| 1) DOXORUBICIN 1 + CL,