MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 20CM

Model Number 360-2080-02

Device Problem Failure to Obtain Sample (2533)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Ten incidents were reported under one product experience report.Argon reached out to the reporter for additional information.Argon did not receive any additional information or ten separate reports for the incidents.The 10 incidents are reported under (comp-(b)(4) ).According to the report, two out of ten samples will be returned for investigation.At this point, it is unclear which samples will get returned.Argon is investigating the reported events and a follow-up report will be submitted when new information becomes available and investigation is completed.

Event Description

Out of 16 biopsies, there were 10 incidents.5 times the gun failed after two or three uses, making vacuum punctures without bringing back pieces of tissue, which increases the attack on the prostate and therefore the risk of hemorrhage and infection and which required for once, 7 guns to make 12 carrots (on average 2) 6 times the procedure was followed by hospitalization or consumption of heavy treatment.- a night hospitalization at the (b)(6) hospital for the same situation of hemorrhage/catheterization with a week of hospitalization for a fragile grandfather - prostatitis with prescription of rocéphine at home - hospitalization in (b)(6) for severe prostatitis bordering on septic shock the same evening of the puncture, rocéphine amiklin, 4 days of hospitalization - a survey for acute urine retention - a hematoma responsible for dysuria, prescription of bactrim and alpha blocker - urethrorrhagia giving in to hyper hydration.(see below for notes/ additional information).

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One unopened sample was returned from the customer for review.A visual inspection was performed on the returned product.Failure to obtain samples was due to the difference from the pincer tip to the window on line 2, which drifted from the settings called out in the procedure.The root cause was identified under capa ca-00042.Line 2's inspection parameters were reset to match the op.This change was then implemented into the software for other gauge sizes.Batches showed improvement based on sampling beef kidneys.

Event Description

Out of 16 biopsies, there were 10 incidents.5 times the gun failed after two or three uses, making vacuum punctures without bringing back pieces of tissue, which increases the attack on the prostate and therefore the risk of hemorrhage and infection and which required for once, 7 guns to make 12 carrots (on average 2) 6 times the procedure was followed by hospitalization or consumption of heavy treatment.A night hospitalization at (b)(6) hospital for the same situation of hemorrhage/catheterization with a week of hospitalization for a fragile grandfather.Prostatitis with prescription of rocéphine at home.Hospitalization in (b)(6) for severe prostatitis bordering on septic shock the same evening of the puncture, rocéphine amiklin, 4 days of hospitalization.A survey for acute urine retention.A hematoma responsible for dysuria, prescription of bactrim and alpha blocker.Urethrorrhagia giving in to hyper hydration.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 20CM
• Type of Device: 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: 18322938
• MDR Text Key: 330428360
• Report Number: 0001625425-2023-01274
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333224043
• UDI-Public: 00886333224043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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
• Device Operator: Health Professional
• Device Model Number: 360-2080-02
• Device Lot Number: 11469345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization