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	Break (1069)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sample has not been returned to argon.Customer information was not provided to follow-up regarding additional information or sample status.This event is being investigated by argon and a follow-up report will be submitted upon investigation completion and when new information becomes available.
Event or Problem Description
Patient undergoing outpatient lung biopsy.During the second biopsy, the device made a strange sound.Device was removed and found to be broken.The locking mechanism would not function and was broke away from it's usual location per operating md.Post procedure ct scan showed a pericardial effusion requiring placement of a pericardial drain.Pt was stabilized and admitted for monitoring.
Event or Problem Description
Patient undergoing outpatient lung biopsy.During the second biopsy, the device made a strange sound.Device was removed and found to be broken.The locking mechanism would not function and was broke away from it's usual location per operating md.Post procedure ct scan showed a pericardial effusion requiring placement of a pericardial drain.Pt was stabilized and admitted for monitoring.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.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.
Additional Manufacturer Narrative
Udi related data quality updates only.

• 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: 17858307
• Report Number: 0001625425-2023-01211
• Device Sequence Number: 5909239
• Product Code: KNW
• UDI-Device Identifier: 00886333224029
• UDI-Public: (01)00886333224029(17)250125(10)11405652
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 01/25/2025
• Device Model Number: 360-1580-02
• Device Lot Number: 11405652
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 09/04/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/09/2023; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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