MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. BIOPINCE FULL CORE WITH OPTIONAL CO-AXIAL NEEDLE-MCXS1820BP; INSTRUMENT, BIOPSY

Model Number 360-2080-01

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

Scheduled ct guided bone marrow aspirate and core under monitored anesthesia care was in progress.The right iliac bone was accessed with an introducer needle and a 1 cm distal tip of the outer cannula of the co-axial introducer needle broke off and was left retained deep within the right iliac bone.The risks of removing the foreign body outweighed the benefit of leaving it in and decision was made to leave the foreign body in place.Case proceeded to conclusion with no additional patient harm or event.Device was not saved for evaluation by biomedical but packaging information retained.

• Brand Name: BIOPINCE FULL CORE WITH OPTIONAL CO-AXIAL NEEDLE-MCXS1820BP
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 12512273
• MDR Text Key: 272684801
• Report Number: 12512273
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360-2080-01
• Device Catalogue Number: 360-2080-01
• Device Lot Number: 11367482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA