MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRU-CORE II BIOPSY INSTRUMENT 20GA X 16CM

Model Number	763120160X
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is indicated as returned.As of the date of this report, sample has not been evaluated.A follow-up report will be submitted once sample is reviewed.
Event or Problem Description
Moved to a posterior approach for the next attempt.After imaging they noticed a small metallic object for the first time and when he looked at the biopsy device he noticed the tip missing and slight deformed look.The device only had one pass when tip broke off.They used another tru core device successfully.The nodule was near rib cage bone and it is a possibility contact to bone was made, but the operator did not feel any tactile feedback that suggested this.The patient saw further evaluation to see if surgical removal was needed and the surgeon advised against it.The tip is in the plural space of the patient.Note- upon receiving the device, the tip is bent at nearly a 90 degree angle.The operating doctor said this type of bend did not occur during the procedure and must have happened after handling for the per.The area of focus is the distal tip.Argon 19g coaxial introducer mcxs2016ty.
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 stylet was bent in two places, one at the distal tip and another 2cm up the stylet.The second bend occurred after leaving the end user, per the representative.It was noticed that the tip of the stylet was missing passed the distal bend.Upon closer observation, it was found that the tip was broken off.The complaint was not confirmed for manufacturing defects.The most likely cause of this issue was hard or fibrous tissue or bone being hit upon insertion or activation.As this issue was most likely due to an event in the user environment, no corrective action was taken.
Event or Problem Description
Moved to a posterior approach for the next attempt.After imaging they noticed a small metallic object for the first time and when he looked at the biopsy device he noticed the tip missing and slight deformed look.The device only had one pass when tip broke off.They used another tru core device successfully.The nodule was near rib cage bone and it is a possibility contact to bone was made, but the operator did not feel any tactile feedback that suggested this.The patient saw further evaluation to see if surgical removal was needed and the surgeon advised against it.The tip is in the plural space of the patient.Note- upon receiving the device, the tip is bent at nearly a 90 degree angle.The operating doctor said this type of bend did not occur during the procedure and must have happened after handling for the per.The area of focus is the distal tip.Argon 19g coaxial introducer mcxs2016ty.

• Brand Name: TRU-CORE II BIOPSY INSTRUMENT 20GA X 16CM
• Common Device Name: TRU-CORE
• 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: 15656408
• Report Number: 0001625425-2022-01116
• Device Sequence Number: 5882207
• Product Code: KNW
• UDI-Device Identifier: 00886333006571
• UDI-Public: 00886333006571
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K982960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: 763120160X
• Device Catalogue Number: 763120160X
• Device Lot Number: 11415620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/23/2022
• Supplement Report FDA Received Date: 12/01/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown