MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 9CM

Model Number	701118090
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is expected to return for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Supercore needles x 4 affected.3 x needles so far have ¿broken apart¿ upon testing.1 x needle did not fall apart on testing, but then broke apart when inside patient.Dr had to retrieve broken needle from patient.Patient not injured.Facility have taken 2 x boxes of the same lot number off the shelf.Please see report form dr.(b)(6).
Additional Manufacturer Narrative
Three opened and ten unopened devices were returned for evaluation.Three opened devices were returned with the body split at the proximal end, and it was noted that the locking tabs were damaged, confirming the complaint.Ten unopened devices were tested, and one of the nine devices split at the body line when test firing the device.Capa 21-001 was initiated to mitigate locking tab breakage on the supercore device.The design of part 3-01-01-196 locking tabs have been improved to require significant increase in pull force to remove the snap fit cap from the snap fit housing.The change was completed (b)(6) 2021.The affected lot was built with locking tabs manufactured prior to the implementation of the capa.
Event or Problem Description
Product fault on supercore¿s for princess alexandra, 4 x needles have fallen apart, with one of the needles falling apart inside a patient.This relates to per0807 and per0806.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 18GA X 9CM
• Common Device Name: SUPERCORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12339619
• Report Number: 0001625425-2021-01069
• Device Sequence Number: 4116211
• Product Code: KNW
• UDI-Device Identifier: 00886333005895
• UDI-Public: 00886333005895
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 701118090
• Device Catalogue Number: 701118090
• Device Lot Number: 11363229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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