MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿

Model Number	70302QC10
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the seeds were stuck in the needle when the radiotherapist put them in place.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the seeds were stuck in the needle when the radiotherapist put them in place.The customer thought the problem comes from the spacer.The customer kept some of the cartridges.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "quicklink¿ cartridges the quicklink¿ cartridges are constructed of radiation-resistant polycarbonate, and hold a maximum of 20 components.The cartridges are marked with a descriptive icon and scale to indicate the identity and approximate quantity of the contained component, as well as provide a visual key for insertion into the loader carriage.Carriage the carriage is designed to hold the quicklink¿ cartridges containing seeds, spacers, and sourcelink¿ connectors.Each slot in the carriage is keyed to a specific cartridge to prevent mix-ups.The carriage may be moved front to back to align the desired component cartridge with the dispensing indicator, or to allow compression and ejection of a seed train.The carriage is also equipped with a quick-release button to allow for carriage removal and inspection.Assembly base and ruler the assembly base is designed to provide a track for the compression of the seeds and sourcelink¿ connectors.The ruler provides a means for verifying that the desired train configuration is obtained prior to delivery into the needle.Dispense button the dispense button transfers one component from the indicated cartridge to the assembly track when pressed.Lead glass door this shielding door is designed to provide radiation protection for the user while allowing for visual inspection of the seed train in the assembly track.The door is automatically latched closed, and may be opened by pressing the door release button on the rear of the assembly base.Compression slide handle the compression slide is designed to deliver the necessary stylet force for compression of the seeds and the sourcelink¿ connectors into a seed train.The compression slide is factory adjusted to ensure that the proper compressive force is delivered every time.The compression slide is fitted with two support doors to minimize buckling of the stylet during compression.Gate button the gate button is designed to control the gate at the end of the assembly track which is the base for compression of sourcelink¿ connectors and seeds.The gate will be closed in normal (up) position to allow for compression.When depressed, the gate will open and allow the seed train to be dispensed through the needle adapter.Needle adapter stainless steel adapters are provided for the attachment of implant needles to the quicklink¿ delivery system.They are designed in 4 different styles to fit all commercially available implant needles.Removable stylet the stylet is designed to compress the seeds and sourcelink¿ connectors into a seed train and has been equipped with a luer-lock fitting for quick and easy".
Event or Problem Description
It was reported that the seeds were stuck in the needle when the radiotherapist put them in place.The customer thought the problem comes from the spacer.The customer kept some of the cartridges.

• Brand Name: QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿
• Common Device Name: QUICKLINK
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7242241
• Report Number: 1018233-2018-00346
• Device Sequence Number: 13494008
• Product Code: KXK
• UDI-Device Identifier: 10801741078092
• UDI-Public: (01)10801741078092
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K023210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2018

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 Expiration Date: 02/23/2018
• Device Model Number: 70302QC10
• Device Catalogue Number: 70303QC20
• Device Lot Number: BBBU0108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/16/2018; 05/14/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/15/2018; 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR