MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿ LOADER; QUICKLINK LOADER

Catalog Number	70310QCA1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
It was reported that the device was not working correctly as the grains were stuck inside of the device.Per follow up, the issue was found during the procedure and the procedure was stopped and rescheduled.
Additional Manufacturer Narrative
The reported event was confirmed; however, the cause in unknown.Initial observation noted that the loader was received with a bent stylet installed.Additionally, the blade arm assembly was not in proper alignment.In this condition, depressing the dispense button would not push a seed or link completely into the slot cover.This condition would create a jam if the carriage was moved.The root cause was pin that holds the blade arm in place was broken.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: "pushing the dispense button does not eject any items or produces a partial dispense." (b)(4).
Event or Problem Description
It was reported that the device was not working correctly as the grains were stuck inside of the device.Per follow up, the issue was found during the procedure and the procedure was stopped and rescheduled.
Additional Manufacturer Narrative
The reported event was confirmed.Initial observation noted that the loader was received with a bent stylet installed.Additionally, the blade arm assembly was not in proper alignment.In this condition, depressing the dispense button would not push a seed or link completely into the slot cover.This condition would create a jam if the carriage was moved.The root cause was the pin that holds the blade arm in place was broken.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: "pushing the dispense button does not eject any items or produces a partial dispense." (b)(4).
Event or Problem Description
It was reported that the device was not working correctly as the grains were stuck inside of the device.Per follow up, the issue was found during the procedure and the procedure was stopped and rescheduled.

• Brand Name: QUICKLINK¿ LOADER
• Common Device Name: QUICKLINK LOADER
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7033070
• Report Number: 1018233-2017-05907
• Device Sequence Number: 1332058
• Product Code: IWJ
• UDI-Device Identifier: 00801741079238
• UDI-Public: (01)00801741079238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2018

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 Catalogue Number: 70310QCA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 12/28/2017; 02/13/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/03/2018; 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1