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

Model Number	360-1080-03
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Renal biopsy performed of left kidney.Biopince ultra full core biopsy instrument, when deployed, would not smoothly access core biopsy sample.Multiple attempts were made and a new biopince ultra was opened.The same difficulty was experienced with the second device resulting in bleeding and hematoma formation that required an intervention.No blood transfusion required.Reference report: mw5118112.
Additional Manufacturer Narrative
A review of the dhrs of the top level and sublots as well as the inspection records was conducted, and 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.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.

• 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: 17138012
• Report Number: 0001625425-2023-01104
• Device Sequence Number: 11735640
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: 00886333224012
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: 360-1080-03
• Device Catalogue Number: 360-1080-03
• Device Lot Number: 11466568
• 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: 06/09/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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