MAUDE Adverse Event Report: ARTHREX, INC. ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA; PLATELET AND PLASMA SEPARATOR

Model Number	ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems (b)(4) that an abs-10062t prp system with aspiration kit wouldn't pull the bone marrow into the separation chamber, but the angel was counting like it was.This occurred during a case where you could hear a slight seeping at the rotor wheel.They tried the same tube in a different angle centrifuge, and it still would not pull the bone marrow.They then transferred the bone marrow into a separate kit, and everything worked fine.There was no effect on the patient.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Evaluation of the complaint allegation was performed per the attached pictures, which show that the device has blood in it.The bone marrow harvest needle was not returned with the kit.The most likely cause of this failure is error user.Per arthrex angel® cprp and bone marrow processing system note: if bma and peripheral blood will be processed separately, it is recommended that peripheral blood is processed first.

• Brand Name: ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
• Common Device Name: PLATELET AND PLASMA SEPARATOR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18103660
• Report Number: 1220246-2023-08644
• Device Sequence Number: 6004178
• Product Code: ORG
• UDI-Device Identifier: 00888867239951
• UDI-Public: 00888867239951
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BK180180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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 Expiration Date: 06/30/2025
• Device Model Number: ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
• Device Catalogue Number: ABS-10062T
• Device Lot Number: 3186133074
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown