THERALOAD
Report
- Report Number
- 1037598-2024-00002
- Event Type
- Injury
- Date Received
- October 17, 2024
- Date of Event
- September 25, 2024
- Report Date
- October 17, 2024
- Manufacturer
- THERAGENICS CORPORATION
- Product Code
- KXK
- UDI-DI
- 00813787020433
- PMA / PMN Number
- K043596
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS INTENDED AS AN INITIAL REPORT AND A FOLLOW UP REPORT WILL BE PROVIDED WITHIN 30 DAYS. INITIAL ASSESSMENT FROM THERAGENICS' MEDICAL AFFAIRS TEAM IS THAT THERE IS POTENTIAL HARM TO THE PATIENT. CONSIDERING THE LOW ACTIVITY (0.357 MCI PER SEED FOR A TOTAL ACTIVITY OF 33.5 MCI) PROVIDED TO THE INTENDED IMPLANT (0.237 MCI PER SEED FOR A TOTAL ACTIVITY OF 25.2 MCI) THE 8 MCI OVER-ADMINISTRATION IMPLANT IS LIKELY NOT HARMFUL. THIS 5-DAY REPORT IS LATE DUE TO THIS BEING THERAGENICS FIRST ELECTRONIC MDR SUBMISSION AND THE REPORT WAS DELAYED DUE TO THE SIGN UP PROCESS. A FOLLOW UP SUBMISSION WILL PERFORMED FOR THE 30-DAY REPORT. INITIAL MEDICAL ASSESSMENT FROM DR.(B)(6): IN MY MEDICAL OPINION THE ERRORS IN THIS CASE ARE MULTIFACTORIAL. FIRST AND AT THE ROOT OF THE PROBLEM IS AN ERROR WHICH OCCURRED IN ERRONEOUS SWITCHING THE PATIENT LABELS AT THE TIME OF MANUFACTURING BETWEEN THE TWO PATIENTS TO BE IMPLANTED ON THE SAME DAY, ONE WITH A MONOTHERAPY DOSE (145 GY OF I-125) AND ONE WITH A BOOST DOSE (110 GY OF I-125). THIS RESULTED IN ONE PATIENT RECEIVING LESS DOSE THEN INTENDED (WHICH CAN BE MADE UP WITH ADDITIONAL SEEDS OR A BIOLOGICALLY EQUIVALENT DOSE (BED) OF EXTERNAL BEAM RADIATION) AND ONE PATIENT RECEIVING MORE DOSE THAN INTENDED ASSUMING EXTERNAL BEAM RADIATION WAS PROVIDED FIRST. IF EXTERNAL BEAM RADIATION WAS NOT PROVIDED FIRST, THEN THE BED CAN BE CALCULATED, AND A DOSE REDUCTION OF THE EXTERNAL BEAM RADIATION CAN BE OPTIMIZED. AT THIS POINT IN TIME THE DOSE AND TIMING OF EXTERNAL BEAM RADIATION ARE NOT KNOWN TO ME. IT SHOULD BE NOTED THAT BOTH PLANS CALLED FOR THE SAME NUMBER OF NEEDLES, BUT THE BOOST CASE CALLED FOR 10 MORE SEEDS AS ORDERED. AT THE CURRENT TIME IT IS NOT KNOW TO ME IF THE ADDITIONAL 4 SEEDS IN 4 INDIVIDUAL NEEDLES WERE IMPLANT OR NOT IN BOTH CASES. THESE FOUR SEEDS AND NEEDLES WERE IN ADDITION TO THE PRE-PLAN AND THE SEED ORDER FOR WHICH I ASSUME WERE EXTRAS TO BE USED IF NEEDED IN ADDITION TO THE PRIMARY PLAN. THE ACTIVITY FOR THE BOOST PLAN (110 GY) WAS 0.237 MCI AND THE ACTIVITY FOR THE MONOTHERAPY PLAN (145 GY) WAS 0.357 MCI. FIVE ADDITIONAL SEEDS WERE SENT WITH EACH CASE WHICH I ASSUME WERE FOR CALIBRATION. THESES SEEDS WERE THE SAME ACTIVITY AS THE ORDERED SEEDS AS ONLY THE PATIENT LABELS WERE SWITCHED IN ERROR. THE SECOND ERROR IS AS FOLLOWS. ALTHOUGH THE SEEDS TRAYS WERE MISLABELED WITH THE OTHER PATIENT'S NAME THE ASSUMPTION OF THE RECEIVER OF THE SEEDS WAS THAT THE SEED TRAYS WERE LABELED CORRECTLY. IF THE ORIGINAL PRE-PLAN WAS COMPARED TO THE SEED LOADING PATTERN OF THE MIS-LABELED TRAY THE ERROR WOULD HAVE BEEN CAUGHT IMMEDIATELY AS THE GEOMETRY OF THE IMPLANTS WERE VASTLY DIFFERENT. ALSO, THE SEED TRAIN LENGTH WAS ALSO SIGNIFICANTLY DIFFERENT WHICH WOULD HAVE BEEN ANOTHER INDICATION THE TRAYS BELONGED TO THE OTHER PATIENT. THE PROSTATE SIZE AND SHAPE WOULD HAVE ALSO BEEN DIFFERENT BETWEEN THE PATIENTS PROVIDING A FINAL CLUE THAT THE TRAYS WERE MISLABELED. UNFORTUNATELY, IN THE END THE SEEDS TRAYS WERE IMPLANTED BASED ON THE MISLABELED ERROR FROM THE MANUFACTURER RESULTING IN THE PATIENTS RECEIVING THE OTHER PATIENTS PLANNED SEEDS. AT THIS TIME, FROM THE INFORMATION PRESENTED IT IS UNLIKELY HARM HAS BEEN DONE TO THE PATIENTS. ONE PATIENT RECEIVED LESS DOSE OF RADIATION THEN INTENDED WHICH CAN BE MADE UP FOR WITH ADDITIONAL SEEDS OR A BED OF EXTERNAL BEAM RADIATION. THE OTHER PATIENT MAY HAVE RECEIVED MORE RADIATION THAN INTENDED IF THE EXTERNAL BEAM RADIATION WAS PROVIDED FIRST, OTHERWISE A BED REDUCTION COULD BE MADE IF IT IS STILL TO BE DELIVERED. IF THE BEAM WAS PROVIDED FIRST POST-IMPLANT DOSIMETRY WILL BE NECESSARY TO MAKE A JUDGEMENT OF THE DOSING TO THE ORGANS AT RISK AND POTENTIAL HARM. CONSIDERING THE LOW ACTIVITY OF THE MONOTHERAPY IMPLANT (0.357 MCI PER SEED FOR A TOTAL ACTIVITY OF 33.5 MCI) PROVIDED TO THE BOOST IMPLANT (0.237 MCI PER SEED FOR A TOTAL ACTIVITY OF 25.2 MCI) THE ADDITIONAL 8 MCI IN A HETEROGENOUS IMPLANT IS LIKELY NOT HARMFUL. AGAIN, THE POST-OPERATIVE DOSIMETRY WILL BE NEEDED FOR FURTHER MEDICAL ASSESSMENT. ALSO KNOWING IF A RECTAL SPACE WAS UTILIZED WILL BE HELPFUL AS WELL AND WOULD BE KNOW AT THE TIME OF POST-OPERATIVE DOSIMETRY ANALYSIS. (B)(6)2024, FOLLOW UP INFORMATION WAS PROVIDED TO OUR MEDICAL AFFAIRS DEPARTMENT: PATIENTS DEMOGRAPHICS/AGE: 72YRS OLD, CAUCASIAN MALE. PROSTATE VOLUME: 23.2 CC. STAGE OF TUMOR, TNM, GS, IPSA, CORE POSITIVITY, MRI FINDINGS AND BIOMARKERS PERFORMED: SATEG IIIC CT3BN0M0 HIGH-VOLUME HIGH RISK ADENOCARCINOMA, GLEASON 4+5+9, PSA 21 MRI SHOWS PI-RADS 5 BILATERAL PERIPHERAL ZONE LESIONS WITH MULTIFOCAL EXTRACAPSULAR EXTENSION INCLUDING LEFT SIDE SEMINAL VESICLE AND NEUROVASCULAR BUNDLE INVOLVEMENT SEQUENCING OF EXTERNAL BEAM RADIATION BEFORE OR AFTER BOOST IMPLANT AND THE DOSE OF EBRT IF PROVIDED BEFORE OR AFTER: 45 GY IN 25 FRACTIONS (1.8GY/FRACTION) WAS DELIVERED BEFORE IMPLANT INTENDED AS BOOST. POST-OPERATIVE DOSIMETRY: PENDING NOT YET AT 1 MONTH FOLLOW-UP INTERVAL FOR CT USE OF RECTAL SPACER: NO. ACTUAL NUMBER OF SEEDS IMPLANTED FOR EACH PATIENT. DID THE USE THE ADDITIONAL NEEDLES AND SEEDS: 76 SEEDS IMPLANTED; 2 SPARES WERE USED. ADT USE AND DURATION: YES, 2 YEARS PLANNED STARTING (B)(6)2024, ADT + ABIRATERONE. WAS THE PRE-PLAN AVAILABLE FOR REVIEW AT THE TIME OF IMPLANT OR WAS THE PLAN THAT WAS PROVIDED WITH THE SEEDS ONLY USED: PRE-PLAN WAS AVAILABLE FOR REVIEW AT TIME OF IMPLANT DID THE PROSTATE SIZE AND VOLUME MATCH UP: YES, PATIENT WAS IMPLANTED WITH MATERIAL LABELED WITH HIS INFORMATION. THE INFORMATION PROVIDED HELP ANSWER THE FOLLOWING QUESTIONS: FOR PATIENT MZ (BOOST DOSE PLANNED BUT RECEIVED MONO DOSE) EXTERNAL BEAM RADIATION WAS DELIVERED PRIOR TO IMPLANT. 4500 CGY WAS PROVIDED IN 25 FRACTIONS (180 CGY PER FRACTION). THE PATIENT HAD HIGH VOLUME, HIGH RISK DISEASE WITH GS 4+5=9, PSA 21 NG/ML, AND AN MRI WITH A PIRAD 5 BILATERAL PERIPHERAL ZONE LESIONS WITH MULTIFOCAL EXTRACAPSULAR EXTENSION INCLUDING LEFT SIDED SEMINAL VESICLE AND NEUROVASCULAR BUNDLE INVOLVEMENT. THE PROSTATE VOLUME IS REPORTED IDENTICAL TO THE MONOTHERAPY CASE OF 23.3 CC. 76 SEEDS WERE IMPLANTED WITH 2 SPARES USED. 4 SPARES WERE ORDERED. DESPITE THE GEOMETRY OF BOTH PATIENTS BEING DIFFERENT ON PRE-PLAN THE CALCULATED VOLUME OF THE PROSTATE WAS REPORTED AS IDENTICAL AT 23.3 CC. 2 YEARS OF ADT ARE PLANNED FOR PATIENT MZ (BOOST DOSE PLANNED BUT RECEIVED MONO DOSE). RECTAL SPACERS WERE NOT UTILIZED IN EITHER PATIENT. THE PRE-PLAN WAS AVAILABLE FOR REVIEW AT THE TIME OF IMPLANT FOR BOTH PATIENTS. ULTIMATELY, THE DAY 30 POST-OPERATIVE IS REQUIRED IN ORDER TO FINALIZE THE MEDICAL ASSESSMENT. IT IS POSSIBLE TO SUPPLEMENT DOSE TO PATIENT WJ WHO WAS PLANNED FOR A MONOTHERAPY DOSE BUT WAS PROVIDED A LOWER BOOST DOSE. (B)(6)2024, AS REQUESTED, THE DAY 30 POST DOSIMENTRIC EVALUATION WAS SENT FOR REVIEW. ALTHOUGH THE GRAPHICAL PLANS WERE NOT SENT FOR FURTHER INTERROGATION OF THE ISODOSE LINES AND EVALUATION OF THE ANATOMIC STRUCTURES THE FOLLOWING SUMMARY WAS PROVIDED BY (B)(6), PH.D., DABR: - PROSTATE VOLUME RECEIVING FULL INTENDED PRESCRIPTION DOSE (110 GY): 26 CC, 99.2% (GOAL: >90%). - DOSE RECEIVED BY 90% OF THE PROSTATE VOLUME: 162.4 GY, 147.7% (GOAL: >90%). - RECTAL VOLUME RECEIVING FULL INTENDED PRESCRIPTION DOSE (110 GY): 0.15 CC, 0.4% (GOAL: <1.3 CC). WE NO LONGER TRACK URETHRAL DOSE POST-IMPLANT AFTER AN INTERNAL ANALYSIS FOUND NO SIGNIFICANT ASSOCIATION OF DOSE WITH IPSS SCORES IN THE FIRST YEAR AFTER SEED IMPLANT. THE INFORMATION PROVIDED DEMONSTRATES THAT THE DOSE PROVIDED TO THE RECTUM OF THE TWO PATIENTS IS MINIMAL AND SHOULD NOT BE A CONCERN FOR TOXICITY. THE SITE IS NOT OVERLY CONCERNED ABOUT URETHRAL DOSE SECONDARY TO INTERNAL WORK DONE ON THIS TOPIC AND URETHRAL METRICS WERE NOT CALCULATED BASED ON THE DEPARTMENTAL PROTOCOL. PATIENT MZ WITH VERY HIGH RISK PROSTATE CANCER WAS IMPLANTED WITH A MONO THERAPY DOSE OF I-125 (145 GY) RATHER THAN THE INTENDED BOOST DOSE OF 110 GY AFTER 45 GY OF EBRT. THE V100 OF THE IMPLANT WITH THE ADDITIONAL DOSE WAS EXCELLENT WITH A V100 OF 99.2 PERCENT WITH A GOAL OF >90 PERCENT. THE ADDITIONAL DOSE COVERED THE ENTIRETY OF THE PROSTATE WHICH CAN BE IMPORTANT IN VERY HIGH RISK DISEASE. THE D90 WAS 162.4 GY, 147.7% (GOAL: >90%). THIS IS A WARM IMPLANT AS WOULD BE EXPECTED HOWEVER CONSIDERING VERY HIGH RISK DISEASE AND VERY LITTLE RECTAL DOSE (THE V100 IS REPORTED AT 0.15 CC WITH A GOAL LESS THAN <1.3 CC) THE PATIENT MAY BENEFIT AND THE LIKELIHOOD OF RECTAL INJURY IS VERY LOW. OVERALL, THE ADDITIONAL INFORMATION PROVIDED PROVIDES COMFORT THAT BOTH PATIENTS HAVE A VERY SMALL PROBABILITY OF EXPERIENCING CLINICAL HARM FROM THE IMPLANTS PROVIDED.
THIS REPORT IS INTENDED AS AN INITIAL REPORT AND A FOLLOW UP REPORT WILL BE PROVIDED WITHIN 30 DAYS. INITIAL ASSESSMENT FROM THERAGENICS' MEDICAL AFFAIRS TEAM IS THAT THERE IS POTENTIAL HARM TO THE PATIENT. CONSIDERING THE LOW ACTIVITY (0.357 MCI PER SEED FOR A TOTAL ACTIVITY OF 33.5 MCI) PROVIDED TO THE INTENDED IMPLANT (0.237 MCI PER SEED FOR A TOTAL ACTIVITY OF 25.2 MCI) THE 8 MCI OVER-ADMINISTRATION IMPLANT IS LIKELY NOT HARMFUL. THIS 5-DAY REPORT IS LATE DUE TO THIS BEING THERAGENICS FIRST ELECTRONIC MDR SUBMISSION AND THE REPORT WAS DELAYED DUE TO THE SIGN UP PROCESS. A FOLLOW UP SUBMISSION WILL PERFORMED FOR THE 30-DAY REPORT.
THE NON-STERILIZED SEEDS AND PAPERWORK INCLUDED IN THE ORDERS WERE LABELED CORRECTLY, BUT THE PRE-STERILIZED NEEDLE TRAYS WERE ALL LABELED INCORRECTLY. THE LABELING OF THE PRE-STERILIZED NEEDLE TRAYS FOR ORDERS (B)(6) WERE INADVERTENTLY SWITCHED WHEN THE LABELING FOR THE NEEDLE TRAYS WERE APPLIED. THERE WERE TWO (2) PRE-STERILIZED NEEDLE TRAYS PER ORDER THAT WERE LABELED INCORRECTLY. SEE ORDERS BELOW: ORDER (B)(6) PATIENT (B)(6). COMPLAINANT SUBMITTED VARISEED NEEDLE LOADING REPORT/PLAN: AGX100 I-125. 0.237 MCI PER SEED. (B)(4) SEEDS, (B)(4) PRE-LOADED NEEDLES. TOTAL ACTIVITY PER PLAN: 20.856 MCI. ORDER (B)(6) PATIENT (B)(6). COMPLAINANT SUBMITTED VARISEED NEEDLE LOADING REPORT/PLAN: AGX100 I-125. 0.357 MCI PER SEED. (B)(4) SEEDS, (B)(4) PRE-LOADED NEEDLES. TOTAL ACTIVITY PER PLAN: 27.846 MCI.
THE NON-STERILIZED SEEDS AND PAPERWORK INCLUDED IN THE ORDERS WERE LABELED CORRECTLY, BUT THE PRE-STERILIZED NEEDLE TRAYS WERE ALL LABELED INCORRECTLY. THE LABELING OF THE PRE-STERILIZED NEEDLE TRAYS FOR ORDERS (B)(4) WERE INADVERTENTLY SWITCHED WHEN THE LABELING FOR THE NEEDLE TRAYS WERE APPLIED. THERE WERE TWO (2) PRE-STERILIZED NEEDLE TRAYS PER ORDER THAT WERE LABELED INCORRECTLY. SEE ORDERS BELOW: ORDER (B)(4) PATIENT (B)(6). COMPLAINANT SUBMITTED VARISEED NEEDLE LOADING REPORT/PLAN: AGX100 I-125, 0.237 MCI PER SEED, 88 SEEDS, 28 PRE-LOADED NEEDLES, TOTAL ACTIVITY PER PLAN: 20.856 MCI. ORDER (B)(4) PATIENT (B)(6). COMPLAINANT SUBMITTED VARISEED NEEDLE LOADING REPORT/PLAN: AGX100 I-125, 0.357 MCI PER SEED, 78 SEEDS, 28 PRE-LOADED NEEDLES, TOTAL ACTIVITY PER PLAN: 27.846 MCI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1288072 | THERALOAD | THERASLEEVE - CUSTOM LOADED NEEDLES | KXK | THERAGENICS CORPORATION | T580156 | 00813787020433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |