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	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/24/2024, it was reported by a sales representative via sems-(b)(4) that an abs-10062t angel® cprp system with aspiration kit had a hole in the tubing and wasn't able to process the blood.This occurred during a case with no patient harm.
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 for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during insertion.

• 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: 20354459
• Report Number: 1220246-2024-07950
• Device Sequence Number: 15089471
• Product Code: ORG
• UDI-Device Identifier: 00888867239951
• UDI-Public: (01)00888867239951(11)240522(17)260331(10)4106140422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/11/2025

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 Expiration Date: 03/31/2026
• Device Model Number: ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
• Device Catalogue Number: ABS-10062T
• Device Lot Number: 4106140422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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