MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE

Model Number	701218200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor wrote; the pistol fired twice without me pressing hard or all the way in.At 2 biopsies, i had difficulty pulling up the biopsy needle via the coaxial.Had to use force.On the way up, i felt that something was scratching the coaxial all the way up.Finally, when i opened the sleeve, i saw that there was a wire-like body in the sleeve along with the biopsy.This one felt like metallic.Unfortunately, i did not take care of the foreign body but only the biopsy needle./coaxial needle.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found that the needle set was bent at the 14cm mark.The needle set and the handle were complete, with no missing or broken pieces.The needle set was straightened out enough to actuate the device.The device was test fired five times with no issues and actuated as designed.The coaxial needle set and the foreign object were not returned.Without these pieces, a comprehensive evaluation could not be performed.Since no manufacturing defects could be found with the product that was returned, the alleged complaint could not be confirmed.A possible cause of the foreign material could not be determined.Since the alleged issue could not be determined to be the fault of a manufacturing defect, no corrective action was taken.
Event or Problem Description
The doctor write: the pistol fired twice without me pressing hard or all the way in.At 2 biopsies, i had difficulty pulling up the biopsy needle via the coaxial.Had to use force.On the way up, i felt that something was scratching the coaxial all the way up.Finally, when i opened the sleeve, i saw that there was a wire-like body in the sleeve along with the biopsy.This one felt like metallic.Unfortunately, i did not take care of the foreign body but only the biopsy needle.Coaxial needle.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
• Common Device Name: SUPERCORE
• 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: 13768111
• Report Number: 0001625425-2022-00963
• Device Sequence Number: 19334598
• Product Code: KNW
• UDI-Device Identifier: 00886333006052
• UDI-Public: 00886333006052
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/26/2026
• Device Model Number: 701218200
• Device Catalogue Number: 701218200
• Device Lot Number: 11352475
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1625425-09/30/2021-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown