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

Model Number	360-1080-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/10/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was cannot be conducted as lot number was not provided.Argon requested additional information to execute proper investigation.The user stated within the event description that the event was not related to a product malfunction.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
Dr.(b)(6) went to biopsy a lymphnode in the right side of a patient groin.Background on patient: had small pe,diffused lymphoma, and on lovenox after biopsy, dr.(b)(6) notice he hit a small accessory artery about 1mm wide.The patient started to bleed.They had to embolize the patient to stop the bleeding.Shortly after the embolization the patient passed away.He claims a 18g bpu was used but doesn't remember the length.Side note: the doctor does not blame the device, but attributes the cause as "bad luck".

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPINCE
• 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: 17941391
• Report Number: 0001625425-2023-01227
• Device Sequence Number: 6472217
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: 00886333224012
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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 Model Number: 360-1080-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death
• Patient Sex: Unknown