MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 I125CE QUICKLINK CARTRIDGE STERILE; BRACHYTHERAPY LINKS & CARTRIDGES

Catalog Number 1251QCSCE

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.H3 other text : device pending return.

Event Description

It was reported that during a brachytherapy procedure, the seeds allegedly broke.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a device history record review was performed for the affected lot number of the cartridge raw material and seeds.These lot met all release criteria.No issues were noted.Investigation summary: the sample was not returned for evaluation.However, a related complaint was created for the received quicklink loader.Looking at the investigation performed for the quicklink loader, the loader was confirmed to be contaminated.This confirms the reported problem as the loader can only be contaminated if a seed was damaged.Therefore, the investigation is confirmed for the reported material deformation issue.The definitive root cause could not be determined based upon the available information.Labeling review: labeling was reviewed and found to be adequate.There is warning statement which states, ¿never implant visibly damaged brachysource seed implants.Brachysource® seed implants should never be handled roughly or forced into any implant device, magazine or needle.Such force may damage the wall of the brachytherapy source, potentially causing release of i-125 into the environment or tissues surrounding an implanted brachytherapy source.Brachysource® seed implants that have been visibly damaged in any way should be sealed in a container and the area monitored for potential i-125 contamination.¿ h10: b5, g3, h6 (method) h11: e1, h6 (result, conclusion) h11: section a through f ¿ the information provided 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 : device not returned.

Event Description

It was reported that during a brachytherapy procedure, the seeds allegedly broke.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: I125CE QUICKLINK CARTRIDGE STERILE
• Type of Device: BRACHYTHERAPY LINKS & CARTRIDGES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer (Section G): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17928350
• MDR Text Key: 325576732
• Report Number: 1018233-2023-07407
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1251QCSCE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1