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

Catalog Number 70302QC10

Device Problems Failure to Discharge (1169); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the linker connector could not discharge from its cartridge.Per email received from the ibc representative on (b)(6) 2019, it was unknown if there was any prolongation for the procedure.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction: d1, d4, g5.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.

Event Description

It was reported that the linker connector could not discharge from its cartridge.Per email received from the ibc representative on 18-nov-19, it was unknown if there was any prolongation for the procedure.

Manufacturer Narrative

This complaint was confirmed, and the root cause was undetermined.Four (4) seed-to-seed cartridges were returned for evaluation.Three (3) of the four samples experienced difficulty expelling the links.When new links were loaded into each of the 4 cartridges, no issues were encountered, and all links were dispensed as expected.The sourcelinks originally contained within the cartridges were viewed under magnification.Some of the links were misshapen and damaged.It was unknown how or when this damage occurred; however, it is unlikely that this damaged occurred at or during the manufacturing process.This is due to the multiple controls that were in place for preventing damage to sourcelinks, e.G.Temperature-controlled storage and labeling during transit, trained and experienced operators handling product, visual inspection prior to product release.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿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." 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.

Event Description

It was reported that the linker connector could not discharge from its cartridge.Per email received from the (b)(6) representative on 18-nov-19, it was unknown if there was any prolongation for the procedure.

• Brand Name: QUICKLINK CARTRIDGE 0.5MM SEED-TO-SEED SOURCELINK
• Type of Device: BRACHY SOURCE SEED
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 9356307
• MDR Text Key: 176283700
• Report Number: 1018233-2019-07468
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• PMA/PMN Number: K023210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70302QC10
• Device Lot Number: BBDX0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1