MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRU-CORE II BIOPSY INSTRUMENT 16GA X 16CM

Model Number	763116160X
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Necrosis (1971)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is expected to return for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Renal puncture was performed in three patients, and bleeding occurred in two patients; another patient was unable to take out the tissue at the first puncture, and the needle is damaged.Four bp were replaced continuously.At the fifth puncture, a large amount of bleeding and necrosis of the right kidney occurred.
Additional Manufacturer Narrative
The customer has indicated that the sample is no longer available for return.Without such evidence to review, the complaint cannot confirmed.If additional information is received in the future, a follow-up report will be submitted.
Event or Problem Description
Renal puncture was performed in three patients, and bleeding occurred in two patients; another patient was unable to take out the tissue at the first puncture, and the needle is damaged.Four bp were replaced continuously.At the fifth puncture, a large amount of bleeding and necrosis of the right kidney occurred.Coaxial was used.

• Brand Name: TRU-CORE II BIOPSY INSTRUMENT 16GA X 16CM
• Common Device Name: TRU-CORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12205158
• Report Number: 0001625425-2021-01035
• Device Sequence Number: 4392629
• Product Code: KNW
• UDI-Device Identifier: 00886333006601
• UDI-Public: 00886333006601
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982960
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 03/03/2025
• Device Model Number: 763116160X
• Device Catalogue Number: 763116160X
• Device Lot Number: 11299534
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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