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 Decreased (4468)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu was reviewed and was confirmed to include hypotony as a known complication and adverse reaction.The device history record for the lot involved was reviewed and no issues were observed.Product was manufactured, tested, and released per validated procedures.Device not returned.If device is returned to nwm, an addendum will be filed to capture evaluation.Surgeon has indicated: "too many fenestrations were created which created hypotony" device is a tube and a plate and the formed bleb controls the iop.The fenestrations can cause the hypotony reported.
Event or Problem Description
Hospital reported, "post-op hypotony.Surgeon determined too many fenestrations were created which created hypotony".
Additional Manufacturer Narrative
Additional information was requested from the initial reporter.On february 8, 2023, the following information was provided: date of implantation: 12/20/2022 date of surgical intervention: (b)(6) 2023.Details of surgical intervention: brought patient into or in attempt to increase iop.Created a paracentesis approximately 180 degrees from the distal end of cp250 tube.Treaded a 4-0 proline suture into the tube lumen in an attempt to increase iop and reduce hyptony.Date of reported event: 2/1/2023.Date of explantation: (b)(6) 2023.Explant is not available for evaluation.Additional event details: persistent hypotony after implanting cp250 in the supranasal quadrant.There was scarring in the supranasal area from a previous vitrectomy.Surgeon felt it is possible too many fenestration holes may have been created.(b)(6) 2023 insertion of the 4-0 prolene was initially successful; increased iop to 19 mmhg.However, when the ligation surture opened iop dropped to 0 mmhg.Course of pressure rise: pre-op iop: 26 mmhg.Post-op iop: 1-3 mmhg.Over next several weeks, iop remained in this range.Patient identifiers: (b)(6).

• 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: 16329206
• Report Number: 1000125279-2023-00002
• Device Sequence Number: 8098770
• Product Code: KYF
• UDI-Device Identifier: 00892064002348
• UDI-Public: (01)00892064002348(11)211024(17)231024(10)L0121
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2023
• Device Model Number: CP250
• Device Catalogue Number: CP250
• Device Lot Number: L0121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2021
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White