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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿; BRACHYTHERAPY LINKS & CARTRIDGES
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QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿; BRACHYTHERAPY LINKS & CARTRIDGES Back to Search Results
Model Number 70303QC10
Device Problems Fitting Problem (2183); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation as well as photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2021).
 
Event Description
It was reported that during a procedure, the device allegedly had a connection problem with the seed when ejected from the loader.It was further reported that incorrect radiation source was delivered to the patient and blockage of the seeds in the needle was noted.There was no reported patient injury.
 
Event Description
It was reported that during a procedure, the device allegedly had a connection problem with the seed when ejected from the loader.It was further reported that incorrect radiation source was delivered to the patient and blockage of the seeds in the needle was noted.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one cartridge was returned to the manufacturer for evaluation.One photo - strands of links and seeds built by the customer was attached within the complaint.After reviewing the photo it was noticed that the links were damaged.The strands were incorrectly built consisting of either 2 female ends placed adjacent to each other, or a female end placed at the beginning or the end of the strand.This sample was used for training in a non-clinical setting, there were 5 links left in the cartridge.The cartridge was inspected and nothing unusual was noted.The cartridge gate closure worked as expected, no spring protrusion on the backside of the cartridge and the plunger traveled appropriately.The cartridge was then placed into a quicklink loader and was able to dispense the links.An attempt was made to link these parts to non-radioactive brachyseeds, which was successful.See attached pictures of strands built using the returned links.Additionally, all of the strands passed through the needle adaptor.A definitive root cause could not be determined based upon the available information.Labeling review: the information for use was reviewed for quicklink delivery system.There is a troubleshooting section described conditions when the sourcelink connectors are not connected to seeds after compression.H10: d4 (expiry date: 11/2021), g3 h11: h6 (device, result, conclusion) h11: section a through f ¿ the information provide by bd represents all 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.H3 other text : see h10.
 
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Brand Name
QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿
Type of Device
BRACHYTHERAPY LINKS & CARTRIDGES
MDR Report Key12334902
MDR Text Key267027307
Report Number1018233-2021-05011
Device Sequence Number1
Product Code KXK
UDI-Device Identifier10801741078108
UDI-Public(01)10801741078108
Combination Product (y/n)N
PMA/PMN Number
K023210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number70303QC10
Device Catalogue Number70302QC10
Device Lot NumberBBFR0056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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