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

Model Number	CP350
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record for the lot reported was reviewed and no issues were observed.Product was manufactured with validated procedures.The ifu was reviewed and it states that the tube must be ligated near the tube-plate junction, preferably with a 7-0 vicryl dissolvable suture to occlude the tube.A 7-0 vicryl dissolvable suture should be placed around the tube and tightened to prevent any flow through the tube.During visual inspection of the returned device, the tube was cut near the tube-plate junction, which suggests that the suture used to occlude the tube was overtightened.
Event or Problem Description
The clearpath 350 broke during insertion.

• 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: 10381299
• Report Number: 1000125279-2020-00023
• Device Sequence Number: 19619429
• 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): 08/05/2020

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: 08/28/2021
• Device Model Number: CP350
• Device Catalogue Number: CP350
• Device Lot Number: 190835007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/07/2020
• 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