MAUDE Adverse Event Report: THERASEED PALLADIUM-103 IN CARTRIDGES; BRACHYTHERAPY LINKS AND CARTRIDGES

Model Number	PS1251CS
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a procedure, the cartridge allegedly jammed and the seeds were not able to be released from the cartridge.There was no reported patient injury.
Event or Problem Description
It was reported that during a procedure, the cartridge allegedly jammed and the seeds were not able to be released from the cartridge.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the affected lot number of the mick cartridge.No issues were noted.Investigation summary: the mick cartridge with 6 seeds was returned together with the mick applicator.The mick cartridge was jammed in the applicator and the seeds were not able to be discharged.With the help of pliers, moderate force , pulling and rotating the cartridge was separated from the applicator.There were 6 seeds inside the mick cartridge among one bent seed.The investigation is confirmed for reported issue, and the root cause is undetermined.Labeling review: labeling was reviewed and found to be adequate.There is a caution statements, which state: "do not overtighten the round magazine head", "do not let seeds drop into the magazine groove" and "do not use force on seeds; handle seeds gently" h11: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.H3 other text : see h10.

• Brand Name: THERASEED PALLADIUM-103 IN CARTRIDGES
• Common Device Name: BRACHYTHERAPY LINKS AND CARTRIDGES
• MDR Report Key: 12157286
• Report Number: 1018233-2021-04179
• Device Sequence Number: 3800581
• Product Code: KXK
• UDI-Device Identifier: 00801741078224
• UDI-Public: (01)00801741078224
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K060636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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 Model Number: PS1251CS
• Device Catalogue Number: TS200CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/26/2021
• 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
• Outcome Attributed to Adverse Event: Other