MAUDE Adverse Event Report: C.R.BARD INC. / BARD PERIPHERAL VASCULAR, INC. BRACHYSOURCE BRACHYTHERAPY SEED; SOURCE, BRACHYTHERAPY, RADIONUCLIDE

Model Number I-125 SEED STM 1251

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, a medical device and its associated components used in the delivery of a permanent radioactive source implant to the prostate did not perform as expected.The prostate seed implant is delivered under sterile conditions in an operating room.The medical device, a radioactive seed about the size of a grain of rice, is shipped to clinics in a pre-loaded cartridge that feeds the seeds into a channel for dispensing, like a magazine.In this instance, the seeds from several cartridges would not dispense.To complete the prescribed treatment, the seeds were manually ejected by the operating personnel from the cartridges, and the loose seeds were used instead.The patient received the planned implant with the malfunction causing about a 30-min delay in the procedure.Immediately after the procedure, an email was sent to the manufacturer, bard, notifying them of the malfunction and to file a complaint.The next day, a representative picked up the empty cartridges for their investigation.On (b)(6), the same representative reported that the malfunction was traced back to the mislabeling of cartridges and gathered some details to send replacement orders for upcoming patient cases.The manufacturer has not yet released a formal report on this event.The event on (b)(6) comes after a period of other minor events that have been reported to the manufacturer involving their equipment.In one example that occurred on (b)(6) 2024, we reported that two cartridges in a patient's seed order had the incorrect number of seeds in them.Cartridges were ordered to have 20 and 10 seeds in them but instead had 19 and 11, respectively.Since radioactive material must be always accounted for, the error in the cartridge loading created the appearance of a lost seed initially and significant resources were spent to locate it.Later the missing seed was accounted for in the cartridge that was supposed to have 10 seeds as it contained 11.We have experienced other events, including issues with dispensing seeds or seeds jamming in the associated equipment.These events have been reported internally and to the manufacturer.Most of these events are still under investigation by the manufacturer.We are concerned with the quality control of the manufacturer.Reference reports mw5152695, mw5152696, mw5152697.

• Brand Name: BRACHYSOURCE BRACHYTHERAPY SEED
• Type of Device: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• Manufacturer (Section D): C.R.BARD INC. / BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 18894193
• MDR Text Key: 337732531
• Report Number: MW5152698
• 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: 03/11/2024

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 Model Number: I-125 SEED STM 1251
• Device Lot Number: BBJN0D89
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1