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

Model Number	360-1580-02
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if sample will get returned for investigation.As of this date, sample was not returned.No images or videos were provided either.Argon inquired about product return and will submit a follow-up report when new information becomes available.
Event or Problem Description
We had two biopince devices fail to obtain samples during a kidney biopsy today despite a good sampling path shown with ultrasound guidance.Each sample was ¿empty¿ when trying to expel the core.Interestingly, there was a core found lying on the patient at one point as if it had fallen from the biopince after obtaining a sample.At least 4 passes were made with each device before finally using a side-cut needle.I believe the devices malfunctioned placing the patient at risk of increased bleeding.Attaching the product packaging labels for reference.Please let me know if any other information is needed.
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.
Event or Problem Description
We had two biopince devices fail to obtain samples during a kidney biopsy today despite a good sampling path shown with ultrasound guidance.Each sample was ¿empty¿ when trying to expel the core.Interestingly, there was a core found lying on the patient at one point as if it had fallen from the biopince after obtaining a sample.At least 4 passes were made with each device before finally using a side-cut needle.I believe the devices malfunctioned placing the patient at risk of increased bleeding.Attaching the product packaging labels for reference.Please let me know if any other information is needed.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 15CM
• 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: 16278079
• Report Number: 0001625425-2023-00954
• Device Sequence Number: 6766326
• Product Code: KNW
• UDI-Device Identifier: 00886333224029
• UDI-Public: 00886333224029
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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: 12/06/2024
• Device Model Number: 360-1580-02
• Device Catalogue Number: 360-1580-02
• Device Lot Number: 11399212
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown