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

Model Number PS1251CS

Device Problem Positioning Failure (1158)

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

Event Date 06/16/2021

Event Type  malfunction  

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 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 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.

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
• Type of Device: BRACHYTHERAPY LINKS AND CARTRIDGES
• MDR Report Key: 12157286
• MDR Text Key: 261205894
• Report Number: 1018233-2021-04179
• Device Sequence Number: 1
• Product Code: KXK
• UDI-Device Identifier: 00801741078224
• UDI-Public: (01)00801741078224
• Combination Product (y/n): N
• PMA/PMN Number: K060636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other