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

Model Number	CP350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Doctor was contacted and further information was requested.According to the customer, there was no patient injury, or surgical intervention required, and the surgery was successfully completed.
Event or Problem Description
After the shunt was placed in the eye and the surgeon tightened the 7-0 vicryl suture, the tail detached.This was for a clearpath model cp350.Date of event not provided.

• 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: 10268314
• Report Number: 1000125279-2020-00021
• Device Sequence Number: 3044619
• Product Code: KYF
• UDI-Device Identifier: 00892064002355
• UDI-Public: (01)00892064002355(11)190828(17)210828(10)190835007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: 08/28/2021
• Device Model Number: CP350
• Device Catalogue Number: CP350
• Device Lot Number: 190835007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/13/2020
• 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