MAUDE Adverse Event Report: I125 SEEDS LOADED IN MICK CARTRIDGES, STERILE; BRACHYTHERAPY LINKS & CARTRIDGES

Model Number	1251CSF
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
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 return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.
Event or Problem Description
It was reported that during a procedure, the seed allegedly would not eject properly.Therefore, that one clogged seed could not be used for treatment, however, it did not affect treatment.There was no reported patient injury.
Event or Problem Description
It was reported that during a procedure, the seed allegedly would not eject properly.Therefore, that one clogged seed could not be used for treatment, however, it did not affect treatment.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review was performed.This lot met all release criteria.Investigation summary: one empty modified mick-15 cartridge - iodinesourcecapcartsterile was returned for evaluation and was labeled as biohazardous.The cartridge was inspected and nothing unusual was noted.15 non-radioactive brachyseeds were linked with sourcecaps.The modified mick -15 cartridge was then loaded with the 15 non-radioactive brachyseeds / sourcecaps, and was inserted into a mick applicator.All 15 non-radioactive brachyseeds with sourcecaps dispensed as expected.Upon completion of dispensing, the cartridge was removed from the applicator and examined.No issues noted.The investigation is not confirmed for the reported issue, and the definitive root cause could not be determined based upon available information.Labeling review: the instruction for use was reviewed for modified mick 15.There is a warning section stating how to handle the magazine when loaded with seeds as well as warning of over tightening the magazine head to the base.H11: d4 (medical device catalog number), h6 (method, result, conclusion).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: I125 SEEDS LOADED IN MICK CARTRIDGES, STERILE
• Common Device Name: BRACHYTHERAPY LINKS & CARTRIDGES
• MDR Report Key: 12365060
• Report Number: 1018233-2021-05166
• Device Sequence Number: 17115593
• Product Code: KXK
• UDI-Device Identifier: 00801741078248
• UDI-Public: (01)00801741078248
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 1251CSF
• Device Catalogue Number: 1251CSF1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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