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

Model Number	70302QC10
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2016
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 there was a connection problem between a connector and a seed in the quicklink loader.Medicon initial visual inspection confirmed that there was no defect in appearance on the returned sample.It is unknown if all the seeds were delivered and/or if there was a prolongation in procedure.Additional information was requested, but not received.
Additional Manufacturer Narrative
The reported issue was inconclusive.The actual sample was not returned for evaluation; however, a photo was provided.The photo showed a single seed-to-seed sourcelink.The quality of the picture did not allow visual verification of any abnormalities.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿caution: avoid damaging the system or using damaged materials.Never use visibly damaged, bent or broken quicklink¿ delivery system loaders, cartridges or components.This may cause system damage or jamming.Do not force cartridges into the carriage slots.The slots are keyed to accept the appropriate cartridges, and minimal effort is required to properly seat the cartridges.When handling this or any other synthetic absorbable material, care should be taken to prevent any damage to the material.Avoid crushing or crimping damage to the cup ends caused by the application of forceps or tweezers.Ensure the needle adapter and stylet are finger-tight.Do not make any other adjustments to the quicklink¿ delivery system.Do not tamper with the mechanisms that reside beneath the carriage when removing the carriage from the loader.These components are aligned to rigid specifications, and must be handled carefully to maintain proper loader functionality.In the event the quicklink¿ loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually.Do not adjust the indicator in the cartridge when the cartridge is loaded.The indicator provides a spring bias to the components to allow for dispensing in the loader, and lifting the indicator and allowing it to snap closed can damage the components and cartridge.Do not re-sterilize sourcelink® connectors or biospacer¿ seeding spacers either loose or in cartridges.The components are supplied sterile and indicated for single use.If desired, radioactive seeds may be removed from a cartridge and re-sterilized.Do not re-sterilize quicklink¿ cartridges.Caution: limitations on use.The quicklink¿ delivery system is prescription use only.Users should be familiar with procedures and techniques involving absorbable spacers and seed train products before using the sourcelink® connectors.Sourcelink® connectors are designed to provide accurate spacing in increments of 0.5cm with typical 4.5mm brachytherapy sources.Use of sourcelink® connectors with brachytherapy sources of other lengths will result in atypical spacing." (b)(4).
Event or Problem Description
It was reported that there was a connection problem between a connector and a seed in the quicklink loader.Medicon initial visual inspection confirmed that there was no defect in appearance on the returned sample.It is unknown if all the seeds were delivered and/or if there was a prolongation in procedure.

• Brand Name: QUICKLINK¿ CARTRIDGE 0.5MM SEED-TO-SEED SOURCELINK¿
• Common Device Name: BRACHY SOURCE SYSTEM
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 6873883
• Report Number: 1018233-2017-04851
• Device Sequence Number: 125634
• Product Code: KXK
• UDI-Device Identifier: 10801741078092
• UDI-Public: (01)10801741078092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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: BBZG0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 01/07/2016
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1