MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. CO-AXIAL INTRODUCER NEEDLE; INSTRUMENT, BIOPSY

Model Number MCXS1810BP

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Biopince failed to obtain sample.Manufacturer response for biopince biopsy device, biopince (per site reporter).They think it's a user error.However, we have had 36 of the same failures within 7 - 8 weeks.

• Brand Name: CO-AXIAL INTRODUCER NEEDLE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 16867514
• MDR Text Key: 314554709
• Report Number: 16867514
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2023,04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCXS1810BP
• Device Catalogue Number: MCXS1810BP
• Device Lot Number: 11468294
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60955 DA
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White