MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM

Model Number	360-1580-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
The patient underwent ct guided puncture biopsy of a mass in the middle lobe of the right lung.Postoperative follow-up ct showed a small amount of pneumothorax.The patient was observed to have no chest tightness or shortness of breath and safely returned to the ward.On the day after surgery, the right chest became more suffocating than before, and the chest pain worsened at night.Upon re examination of the chest x-ray, the amount of pneumothorax increased.A closed drainage surgery was performed on the right chest, and a large amount of gas was introduced through the placement of a chest drainage tube.The patient did not experience any significant discomfort after the surgery.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.No corrective action is required at this point.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 20652668
• Report Number: 0001625425-2024-01130
• Device Sequence Number: 18204759
• Product Code: KNW
• UDI-Device Identifier: 00886333004355
• UDI-Public: (01)00886333004355(17)251214(10)11454375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2025
• Device Model Number: 360-1580-01
• Device Lot Number: 11454375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian