THERASEED PALLADIUM 103 IMPLANTS

Description of Event or Problem

DISTRIBUTOR MIS-KEYED THE PRESCRIBED ACTIVITY FOR THIS PROSTATE BRACHYTHERAPY ORDER, SPECIFYING 1.28 U SK,N99 (BASED ON THE NIST 1999 WAFAC STANDARD), WHEN THE USER REQUESTED 1.28 MCI AAPP,T97 (BASED ON THE CD-109 STANDARD). MFR FILLED THE ORDER AS 1.28 U SK,N99. DISTRIBUTOR AND USER RECEIVED FAX CONFIRMATIONS OF THE ORDER PRIOR TO SHIPMENT, BUT DID NOT DETECT THE ACTIVITY DISCREPANCY. USER'S RECEIVING PROCEDURES FOR THE INCOMING ORDER ALSO DID NOT REVEAL THE ACTIVITY DISCREPANCY. THE ORDER WAS IMPLANTED IN 2001 AT AN ACTIVITY OF 0.74 MCI AAPP,T97 RATHER THAN THE PLANNED 1.28 MCI AAPP,T97, RESULTING IN A 41% MISADMINISTRATION (LOWER ACTIVITY THAN PRESCRIBED). THERAGENICS WAS NOTIFIED OF THE EVENT BY THE USER IN 4/2001. THE PT HAS NOT, AND WILL NOT, EXPERIENCE PERMANENT IMPAIRMENT OR DAMAGE FROM THIS MISADMINISTRATION. THE MISADMINISTRATION IS BEING REPORTED AS A MDR ADVERSE EVENT, BECAUSE THE DOSE DELIVERED WAS LIKELY NOT HIGH ENOUGH TO BE EFFICACIOUS FOR THE INTENDED TREATMENT OF PROSTATE CANCER, AND FOLLOW-UP THERAPY WILL POTENTIALLY BE REQUIRED TO COMPLETE THE PT'S TOTAL TREATMENT. THERAGENICS HAS REFERRED THE USER FOR CONSULTATION TO AN ONCOLOGIST EXPERIENCE IN PERFORMING EXTERNAL BEAM BOOST TREATMENTS FOLLOWING PROSTATE SEED IMPLANTS. THE DEVICE ORDER WAS IMPLANTED AND, THEREFORE, NOT RETURNED FOR CORRECTION. NO OTHER PTS OR ORDERS HAVE BEEN, NOR WILL BE, AFFECTED BY THIS ACTIVITY DISCREPANCY.