MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18GX10CM

Model Number	360-1080-01
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been returned for evaluation.A follow-up report will be submitted once the investigation has been completed.Placeholder.
Event or Problem Description
I was to perform a ct guided lung biopsy to diagnose what was assumed to be a lung cancer.After placement of a coaxial needle into the nodule, the first two biopince needles yielded no sample (these are the needles that have been returned).This lead to a delay in the procedure during which the patient developed a pneumothorax (collapsed lung) and the coaxial needle position was lost.Although a collapsed lung is a recognized complication, the delay in the procedure due to equipment failure is likely to have significantly worsened this situation.Although we attempted a third sample with another needle which did provide a sample, by this point coaxial needle position had been lost and the sample was negative for cancer (due to incorrect needle position).The patient also needed admitted to hospital for several days rather than be discharged that afternoon.In summary, biopsy needle failure x2 is likely to have been a significant contributor to lung collapse development and non-diagnostic sample given the time delay introduced.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text: placeholder.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11572532
• Report Number: 1625425-2021-00884
• Device Sequence Number: 4010050
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: 00886333004379
• Combination Product (Y/N): N
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 12/09/2023
• Device Model Number: 360-1080-01
• Device Catalogue Number: 360-1080-01
• Device Lot Number: 11343087
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other