MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿ CARTRIDGE 0.5MM SEED-TO-SEED SOURCELINK

Model Number	70302QC10
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
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 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: "ensure compression slide has been fully reset before compression; stylet bent ¿ replace; the seed train is incorrectly built consisting of either two female or two male ends placed adjacent to each other; ensure the sourcelink connector material is not damaged preventing compression.Ensure the lead glass cover is securely closed; do not press the gate button during compression, allowing ejection of unlinked components through the needle adapter.Ensure that the handle is not being pulled while the dispense button is being depressed.Pulling on the handle during dispensing can cause the cartridge to become misaligned with the dispense track, resulting in a lock out or a jam; ensure the selected cartridge is fully seated in the corresponding carriage receptacle; remove cartridge from carriage and reinsert back into the carriage.Ensure the dispense blade is not jammed - remove the carriage and inspect dispense blade, verify there are no loose components; the selected cartridge is empty - replace with a full cartridge; the dispense button is not fully depressed - press button fully.If cartridge does not dispense following troubleshooting, replace cartridge.Ensure that you hold the gate button down while sliding the releasable slide.Ensure the seed train has been properly built and does not include damaged components ensure needle adapter is appropriate for the implant needle used.Ensure needle adapter is appropriate for the implant needle used." 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.

• Brand Name: QUICKLINK¿ CARTRIDGE 0.5MM SEED-TO-SEED SOURCELINK
• Common Device Name: QUICKLINK
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7242235
• Report Number: 1018233-2018-00345
• Device Sequence Number: 11056877
• 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
• Report Date (Section B): 04/13/2018

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 Model Number: 70302QC10
• Device Catalogue Number: 70302QC10
• Device Lot Number: BBBU0106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 DA