MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM

Model Number 360-1080-01

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device is indicated as available for evaluation.As of the date of this report, the device has not yet been returned.A follow-up report will be provided once more information is received and reviewed.

Event Description

Number of patient: 1.Position: prone.Lesion location:apical segment (s i) of right lung.Lesion size:= 1.0 cm.Technique: co-axial (mcxs1810bp).Result: incomplete sample (empty gun).Complication: parenchymal hemorrhage.

Event Description

Follow up.

Manufacturer Narrative

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• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10515414
• MDR Text Key: 207563849
• Report Number: 1625425-2020-00516
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: 00886333004379
• Combination Product (y/n): N
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: 360-1080-01
• Device Catalogue Number: 360-1080-01
• Device Lot Number: 11275526
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other