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

Model Number	CP250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure, Delayed, Uncontrolled (1936)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu was reviewed and it includes hypotony as a known complication and adverse reaction.The device history record was reviewed for compliance and no issues were observed.The shunt was not explanted and not available for evaluation to determine cause of report.
Event or Problem Description
Placement of ahmed 250 (b)(4) on (b)(6) 2019 with 7-0 vicryl ligature and fenestrations.Pt had a small avascular leaking bleb that had to be closed.Iop 9-10 post-op.On (b)(6) 2020: 2 months after implantation iop 2 hypotony persisted with development of choroidals.Exploration in or (b)(6) 2020: the entire conjunctival flap had not healed onto the globe.Aqueous was leaking underneath creating the hypotony.The area was extensively cauterized and resutured.On (b)(6) 2020 again leaking along the suture lines, large bandage ctl was placed.

• Brand Name: AHMED CLEARPATH
• Common Device Name: GLAUCOMA SHUNT
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison ct.; rancho cucamonga, ca
• MDR Report Key: 9955772
• Report Number: 1000125279-2020-00012
• Device Sequence Number: 16703933
• Product Code: KYF
• UDI-Device Identifier: 00892064002348
• UDI-Public: (01)00892064002348(11)191023(17)211023(10)191025009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2021
• Device Model Number: CP250
• Device Catalogue Number: CP250
• Device Lot Number: 191025009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR