MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 PALLADIUM-103 IN CARTRIDGES WITH SOURCECAP; BRACHYTHERAPY SEEDS

Catalog Number	TS200CSF
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a brachytherapy procedure using brachytherapy implant needles.During the procedure, it was reported that there was an obstruction occurred in the mick applicator system which resulted in blockage, leading to the termination of the procedure.Reportedly there was a delay in surgery.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection / evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device / patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H11: manufacturing review: a sales order and device history record (dhr) review was performed, and no issues were noted.Investigation summary: there were seven (7) cartridges returned for this complaint.Five (5) cartridges were able to have the seeds dispensed.One (1) cartridge was jammed from the procedure and was radioactively contaminated; therefore, that cartridge was stored for decay and could not be tested further.One (1) cartridge jammed while dispensing seeds and the cartridge was unable to be removed from the applicator, confirming the reported issue.Six (6) cartridges were tested against the raw material inspection and passed all acceptance criteria.The root cause was undetermined.This complaint is confirmed, and the root cause is undetermined.The design failure mode and effects analysis and process failure mode and effects analysis adequately address the potential for the alleged malfunction in this complaint.Labeling review: the information of use for this customer sales order is pk0319943 12/2018.There is a statement which states ¿do not handle mick cartridges by the spring-loaded plunger.Do not exceed the maximum loading capacity per cartridges (15 seeds).Do not overtighten the round mick cartridges head.Do not let seeds drop into cartridges groove.Do not use force on seeds or cartridges.Do not force cartridges into applicator, and do not forcibly remove cartridges from applicator.¿ there is also references to the manufacturer¿s instructions for use for the palladium-103 seeds for additional warnings and precautions.G3, h6 (component, method, result).Section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent a brachytherapy procedure using brachytherapy implant needles.During procedure, three separate obstructions occurred in the mick applicator system.Despite using new seed cartridges and applicators, each attempt resulted in blockage, leading to the termination of the procedure.Reportedly had surgical delay.There was no reported patient injury.

• Brand Name: PALLADIUM-103 IN CARTRIDGES WITH SOURCECAP
• Common Device Name: BRACHYTHERAPY SEEDS
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer (Section G): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23164405
• Report Number: 1018233-2025-08627
• Device Sequence Number: 21242603
• Product Code: KXK
• UDI-Device Identifier: 00801741078439
• UDI-Public: (01)00801741078439
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K060636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: TS200CSF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown