MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (18GX10CM)

Model Number	360-1080-03
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Perforation (2001); Respiratory Insufficiency (4462)
Date of Event	10/27/2022
Type of Reportable Event	Death
Event or Problem Description
The following report was sent to argon by the hospital and also sent to fda and is cited as follows: on (b)(6) 2022, patient went to interventional radiology for a liver biopsy using the biopince ultra 18g.Postprocedure, the patient developed respiratory distress prompting a chest ultrasound which showed bleeding in the right chest.Pigtail placed for drainage; however, bleeding persisted and the patient was taken to the operating room for chest exploration.Patient found to have a puncture site in the right lower lobe with significant amount of blood loss within the chest.It's believed that the device misfired at a longer distance than what was set.
Additional Manufacturer Narrative
Warnings listed in ifu: reuse or reprocessing has not been evaluated and may lead to its failure and subsequent patient illness, infection or other injury.Do not reuse, reprocess or re-sterilize this instrument.Inspect the package integrity before use.Do not use if package is open or damaged or if the expiry date has been exceeded.The instrument should be used by a physician familiar with the possible side effects, typical findings, limitations, indications and contraindications of core needle biopsy.Use only for core biopsies of soft tissue as determined by a licensed physician.Attempting to biopsy hard tissue or masses may reduce the performance, causing damage to the instrument or potentially harm the patient.This instrument is intended for soft tissue biopsy only.Incorrect setting of stroke length on the device may cause a sample to be incorrectly taken.Handle in a manner, which will prevent accidental puncture.According to the ifu (pmt-z9585746-0221), the instrument is shipped in the 33mm stroke length position.To adjust the stroke length, push in the stroke length adjuster (e) and slide the stroke length adjuster until the arrow the on the stroke length adjuster aligns with the arrow of the desired stroke length on the instrument.Review of the device history record shows that the device met specification as manufactured.The procedure is to be done under imaging.It is not known at this time if imaging was performed.Scans were requested but were not provided.The device is not available for evaluation.When the biopsy needle is not completely seated in position to take the desired sample (i.E., 13mm, 23mm or 33mm), the throw adjuster can travel to the next sample size.If the user fails to properly align the device prior to use, then the needle can travel further than expected which may result in hemorrhage.In this particular case the patient had a thoracic bleed and expired.If additional information is provided in the future, this issue will be reevaluated as needed and a follow-up report will be submitted.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (18GX10CM)
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15878540
• Report Number: 0001625425-2022-01140
• Device Sequence Number: 2468510
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: 00886333224012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/27/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2025
• Device Model Number: 360-1080-03
• Device Catalogue Number: 360-1080-03
• Device Lot Number: 11435288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Death
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Ethnicity: Non Hispanic