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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/07/2025, a sales representative reported via (b)(4) that an abs-10062t angel® cprp system with aspiration kit had no fluid coming out.This occurred during a case that went full cycle, a seventeen-minute spin, and showed cc; however, fluid did not come out.Additional information was provided on 02/26/2025 where the sales representative stated this event occurred on (b)(6) 2025 during an achilles case.The patient went without prp for this case.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to user error due to not striking the syringe prior to installation.

• 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: jared engle ; 8009337001
• MDR Report Key: 21524605
• Report Number: 1220246-2025-00785
• Device Sequence Number: 8455085
• Product Code: ORG
• UDI-Device Identifier: 00888867239951
• UDI-Public: (01)00888867239951(11)240101(17)261231(10)4185150726
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/26/2025

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: ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
• Device Catalogue Number: ABS-10062T
• Device Lot Number: 4185150726
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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