MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. AHMED CLEARPATH; GLAUCOMA DRAINAGE DEVICE

Model Number	CP250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dhr for the reported lot was reviewed with no issues found.Product was manufactured, tested, and released in compliance with nwm procedures.Communication with the reporter found that the patient recovered 6 days post-op.Device not available for evaluation as no explant was necessary.No device issues confirmed.
Event or Problem Description
Ligation and fenestrations were performed on device.Post-operation day 1 patient presented with a 40 iop and was prescribed diamox and combigan.Post-day 6 patient was "doing okay" per doctor.

• Brand Name: AHMED CLEARPATH
• Common Device Name: GLAUCOMA DRAINAGE DEVICE
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9098705446
• MDR Report Key: 17941329
• Report Number: 1000125279-2023-00029
• Device Sequence Number: 6472202
• Product Code: KYF
• UDI-Device Identifier: 00892064002348
• UDI-Public: (01)00892064002348(11)230722(17)250722(10)G0623
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/22/2025
• Device Model Number: CP250
• Device Catalogue Number: CP250
• Device Lot Number: G0623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female