MAUDE Adverse Event Report: ARGON MEDICAL DEVICES PRO-MAG BIOPSY NEEDLES

Model Number	765018160
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as available for evaluation.As of the date of this report, it has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
Once the needle is in the nodule/patient, the physician was unable to insert the needle into the promag.Impossible to perform the biopsy.Another needle was used with success with the same gun.The excess manipulation resulted in a pneumothorax for the patient.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text : placeholder.
Event or Problem Description
Follow up.

• Brand Name: PRO-MAG BIOPSY NEEDLES
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10646747
• Report Number: 1625425-2020-00581
• Device Sequence Number: 18975609
• Product Code: KNW
• UDI-Device Identifier: 00886333006854
• UDI-Public: 00886333006854
• Combination Product (Y/N): N
• PMA/510(K) Number: K980226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2024
• Device Model Number: 765018160
• Device Catalogue Number: 765018160
• Device Lot Number: 11280216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/20/2020; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other