MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ACCURA BLN 20G X 7.5CM, WIRE 19.4CM

Model Number	BLN20075
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Following the placement of a simple harpoon under ultrasound control at the level of the qse lesion, the latter migrated inside the breast of mrs.A-ds.The mammography image then taken showed us that the harpoon had migrated with a proximal end at the level of the qse and a distal end in the pre-pectoral area.A second double j harpoon was then placed.Good positioning on the control shots.The gynecologist managed to remove the defective harpoon from the patient's breast.It turns out that it is defective: no hook or the hook has not deployed.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
Following the placement of a simple harpoon under ultrasound control at the level of the qse lesion, the latter migrated inside the breast of mrs.(b)(6).The mammography image then taken showed us that the harpoon had migrated with a proximal end at the level of the qse and a distal end in the pre-pectoral area.A second double j harpoon was then placed.Good positioning on the control shots.The gynecologist managed to remove the defective harpoon from the patient's breast.It turns out that it is defective: no hook or the hook has not deployed.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened needle was returned for evaluation.Visual inspection found the needle to be bent from use, with the harpoon present.The cannula was not returned for investigation.It is possible that the needle had moved within the cannula before insertion into the patient, which could cause the marker to not deploy correctly.Without any images, this could not be confirmed.Since the complaint could not be confirmed, no corrective action was taken.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: ACCURA BLN 20G X 7.5CM, WIRE 19.4CM
• Common Device Name: BLN
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18122536
• Report Number: 0001625425-2023-01235
• Device Sequence Number: 12481334
• Product Code: GAA
• UDI-Device Identifier: 00886333007493
• UDI-Public: (01)00886333007493(17)271223(10)11456180
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: BLN20075
• Device Lot Number: 11456180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 09/01/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/17/2023; 09/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown