MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM

Model Number	360-1080-03
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample expected to return for evaluation.A follow-up report will be provided once the sample has been received and reviewed.
Event or Problem Description
Device was prepared at 3.3cm throw.Upon attempting to take a sample, no tissue was obtained.However, blood came from the introducer indicating we had punctured the liver.Tried again, again no tissue.We used a new biopsy device and gelfoam for hemostasis.
Additional Manufacturer Narrative
Argon has made three requests for the return of the sample for evaluation.As of the date of this report, the sample has not been returned.Without such evidence to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
Device was prepared @ 3.3cm throw.Upon attempting to take a sample, no tissue was obtained.However, blood came from the introducer indicating we had punctured the liver.Tried again, again no tissue.We used a new biopsy device and gelfoam for hemostasis.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM
• Common Device Name: BIOPINCE ULTRA
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12013476
• Report Number: 0001625425-2021-00999
• Device Sequence Number: 11705976
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: 00886333224012
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 01/25/2024
• Device Model Number: 360-1080-03
• Device Catalogue Number: 360-1080-03
• Device Lot Number: 11349411
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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