MAUDE Adverse Event Report: ARTHREX, INC. ANGEL CPRP PROCESSING SET USM; PLATELET AND PLASMA SEPARATOR

Model Number	ANGEL CPRP PROCESSING SET USM
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2024
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 3/20/2024, a facility representative via (b)(4) reported that an abs-10063 cprp processing set tubing was punctured when used, creating a hole during the procedure and causing blood to pour out.The patient's blood had to be re-drawn due to the issue to complete the case.This was discovered during a procedure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, 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.
Event or Problem Description
Additional information was received on 4/30/2024: this was discovered during a clinical setting of a prp of the ankle procedure on (b)(6) 2024.There was a delay after this happened and therefore had to start all over including blood draw again on the patient.The case was completed using abs-10063 prp processing set, arthrex angel system.

• Brand Name: ANGEL CPRP PROCESSING SET USM
• 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: 19095562
• Report Number: 1220246-2024-02002
• Device Sequence Number: 7428776
• Product Code: ORG
• UDI-Device Identifier: 00888867084001
• UDI-Public: 00888867084001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 07/31/2026
• Device Model Number: ANGEL CPRP PROCESSING SET USM
• Device Catalogue Number: ABS-10063
• Device Lot Number: 2023080033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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