MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT

Catalog Number 360-1080-01

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Air Embolism (1697); Death (1802)

Event Date 11/05/2019

Event Type  Death  

Manufacturer Narrative

We understand from the distributor that lot 11268312 (part number 360-1080-01) was used in a lung biopsy procedure on a (b)(6) male patient with lymphoma.We also understand that this procedure was done co-axially.Generally, if used without co-axial guidance, incisional dermatotomy is recommended prior to activating the biopince device through the skin.The patient is said to have died from an air embolism after the procedure.The sales rep stated that the physician told him that the surfaces of the referenced biopince needle were smooth before the lung biopsy procedure was performed and that it was discarded after use and is no longer available.The instructions for use for the device clearly state that the user should verify the integrity of the needle before cocking the instrument and after firing(s).If any damage to the needle are observed, the user should promptly discard the entire device and prepare a new instrument.The physical device was not returned to argon and no photo of the particular unit actually used on the patient was provided to us as part of the initial communication.Review of the device history record does not show any anomalies or nonconformances during manufacture.Argon has no similar reports in its database.There were no similar product complaints for this lot number.Although requested, further details on the patient condition or medical history, and the operative methods during the biopsy are not available to argon.The actual product used on the patient was discarded by the hospital staff and is not available for further evaluation.There is no photograph of the actual 10 cm product used in the patient.Therefore, no definitive conclusion can be given for this patient experience.It appears the likelihood that this is due to a biopince malfunction is remote.

Event Description

The incident took place in (b)(6) where a (b)(6) boy died after a lung biopsy.According to the information obtained from the staff there, the tip of the metal needle opens easily.The patient was an oncology patient who died shortly after the lung biopsy procedure.The patient is said to have died from an air embolism after the procedure.

• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT
• Type of Device: AUTOMATIC FULL CORE BIOPSY INSTRUMENT
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 9392176
• MDR Text Key: 168570718
• Report Number: 1625425-2019-00282
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): Y
• Reporter Country Code: IS
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Catalogue Number: 360-1080-01
• Device Lot Number: 11268312
• 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: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 15 YR