MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM

Model Number	360-1080-02
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported "during a thyroid biopsy, the doctor had selected a needle advance of 1.3 cm.When shooting, the needle has advanced 3.3 cm, so it has crossed the vertebral artery, causing hemorrhage in the patient very difficult to control.The event has been serious and there is talk of the possibility of creating a health alert".
Additional Manufacturer Narrative
Sample is indicated as available for return.As of the date of this report, sample has not been returned.A follow-up report will be submitted once the sample has been received and reviewed.
Additional Manufacturer Narrative
Sample is indicated as returned.A follow-up report will be submitted once the sample has been evaluated.
Event or Problem Description
Physician reports that during a thyroid biopsy, the doctor had selected a needle advance of 1.3 cm.When shooting, the needle has advanced 3.3 cm, so it has crossed the vertebral artery, causing hemorrhage in the patient very difficult to control.The event has been serious and there is talk of the possibility of creating a health alert.Hospital rejected the stocked units of that device and will send them to our company.Hospital needs too, a letter explaining the root cause of the incident and wacrees needs credit note per all units returned back to wacrees of the same reference.(we'll know it very soon).
Event or Problem Description
Physician reports that during a thyroid biopsy, the doctor had selected a needle advance of 1.3 cm.When shooting, the needle has advanced 3.3 cm, so it has crossed the vertebral artery, causing hemorrhage in the patient very difficult to control.The event has been serious and there is talk of the possibility of creating a health alert.Hospital rejected the stocked units of that device and will send them to our company.Hospital needs too, a letter explaining the root cause of the incident and wacrees needs credit note per all units returned back to wacrees of the same reference.(we¿ll know it very soon).
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.A used sample and 50 sealed samples were returned to argon from the customer.An inspection was performed on the returned product.The inspection established that the device can fire within the specified stroke length chosen.It is possible that the device was not fully seated in the detent of the device.When the biopsy needle is not completely seated in position to take the desired sample (ie: 13mm, 23mm or 33mm), the throw adjuster can travel to the next sample size.According to the ifu (pmt-x9585746-0221), the instrument is shipped in the 33mm stroke length position.To adjust the stroke length, push in the stroke length adjuster and slide it until the arrow on the stroke length adjuster aligns with the arrow of the desired stroke length on the instrument.It can be visually detected that the stroke length adjuster aligns with the arrow of the desired stroke length on the instrument.If properly aligned, the user will feel the stroke adjuster slide into the detent.There is also an audible sound when the detent is engaged.Hhe 1278 has been conducted to evaluate the impact and it was determined that no field action will be required at this time.Since the manufacture of this lot, argon has strengthened the warnings on the ifu to emphasize the potential danger of this issue.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM
• 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: 16088972
• Report Number: 0001625425-2023-00917
• Device Sequence Number: 2147568
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: 00886333224005
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2023

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: 06/07/2025
• Device Model Number: 360-1080-02
• Device Catalogue Number: 360-1080-02
• Device Lot Number: 11425482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 12/14/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/16/2023; 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown