MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G X 15CM

Model Number 370-1580-01

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Necrosis (1971)

Event Date 04/29/2021

Event Type  Injury  

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 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.

Manufacturer Narrative

The customer had indicated that the sample is no longer available to return.Without the sample to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be submitted.

Event 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: BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G X 15CM
• Type of Device: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12205020
• MDR Text Key: 262728673
• Report Number: 0001625425-2021-01034
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333004362
• UDI-Public: 00886333004362
• Combination Product (y/n): N
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2023
• Device Model Number: 370-1580-01
• Device Catalogue Number: 370-1580-01
• Device Lot Number: 11313593
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 07/05/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other