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

Model Number	360-1580-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaints database was conducted.Over the previous six months, no similar complaints were found related to this product family and no similar complaints related to part number.There were no other complaints found related to lot.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.
Event or Problem Description
On (b)(6) 2022, a follow-up chest ct scan showed slight pulmonary bleeding and moderate pneumothorax around the puncture site.A guide wire was inserted along the electromagnetic navigation puncture needle, the skin opening was dilated, and a thoracic puncture tube was inserted along the guide wire.A fixed puncture tube with a depth of 15cm was left in the chest cavity, and an external drainage bucket was connected.A moderate amount of gas was extracted, and sterile dressing was used for dressing.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM
• Common Device Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19198920
• Report Number: 0001625425-2024-01003
• Device Sequence Number: 12842334
• Product Code: KNW
• UDI-Device Identifier: 00886333004355
• UDI-Public: (01)00886333004355(17)251117(10)11450482
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Model Number: 360-1580-01
• Device Lot Number: 11450482
• Was Device Available for Evaluation?: No
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 04/27/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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 Sex: Unknown