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

Model Number	ANGEL SYSTEM WITH ASPIRATION KIT
Medical Device Problem Codes	Material Puncture/Hole (1504); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 2/23/2024, it was reported by a sales representative via (b)(4) that an abs-10063 cprp processing set was damaged with no further information provided.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b.5: event updated.G.3: follow-up information received.H.6: updated corrections: d.1: brand name updated.D.4: model number, catalog number, lot number updated.
Event or Problem Description
Additional information was received on 3/12/2024 via phone: the abs-10062 arthrex angel bmc kit had a hole in the tubing.This was discovered during a bone marrow aspiration procedure (b)(6) 2024.There was no delay in the case reported and the case was completed using a abs-10063 cprp processing set, arthrex angel system with no adverse effects on the patient.
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 misuse/mishandling due to damage to the device.

• Brand Name: ANGEL SYSTEM WITH ASPIRATION KIT
• 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: 18879636
• Report Number: 1220246-2024-01418
• Device Sequence Number: 9255509
• Product Code: ORG
• UDI-Device Identifier: 00888867084001
• UDI-Public: 00888867084001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• 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,Followup
• Report Date (Section B): 06/24/2025

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: 06/30/2026
• Device Model Number: ANGEL SYSTEM WITH ASPIRATION KIT
• Device Catalogue Number: ABS-10062
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 06/04/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/15/2024; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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