MAUDE Adverse Event Report: ISORAY MEDICAL, INC CESIUM 131 BRACHYTHERAPY SEEDS; SOURCE, BRACHYTHERAPY, RADIONUCLIDE

Model Number CS-1 REV 2

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

On october 13, one (1) cs-131 seed was identified outside of shielded vial with the other 94 seeds intact within the shielded vial.The one seed outside the shielded vial was found in the sealed bag which surrounds the shielded vial all within the shipping container.Please note this shield container is designed with small holes in the bottom so sterilization of the seeds can be achieved.Discovered one (1) mick cartridge with 4 seed inserted ( not the expected 5 seeds), the 1 seed outside the shielded container totals the 95 seeds ordered.After the seed was contained in a shielded environment, the package material including the plastic bag, both inside and outside of the shipping container was both surveyed and wipe tested.Additionally the loose cs-131 seed was wiped tested and showed no evidence of removable contamination.All 95 seeds are currently secured in the shielded container marked for decay and future disposal within nuclear medicine hot lab.Replacement seeds are being sent for patient brachytherapy procedure with hopefully no delay in service.Fda safety report id #(b)(4).

• Brand Name: CESIUM 131 BRACHYTHERAPY SEEDS
• Type of Device: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• Manufacturer (Section D): ISORAY MEDICAL, INC; richland WA 99354
• MDR Report Key: 15667915
• MDR Text Key: 302570814
• Report Number: MW5112827
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: CS-1 REV 2
• Device Lot Number: DO2242-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1