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

Model Number FP7

Device Problem Failure to Prime (1492)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record for the lot reported was reviewed and no issues were observed the product was manufactured, tested and released in compliance with procedures.Customer was contacted and asked for the sample for evaluation without a sample for evaluation we are unable to determine what caused the issue reported.

Event Description

Device failed to irrigate properly.No injury to patient.Device removed immediately from the field and replaced.

Manufacturer Narrative

Customer provided unused valve for evaluation.The unit was visually and functionally tested and it performed in compliance with specification.The unit was first primed as indicated in the ifu and no issues were observed.A steady state test was completed.The valve was able to maintain the required pressure over time.

Event Description

Device failed to irrigate properly.No injury to patient.Device removed immediately from the field and replaced.

• Brand Name: AHMED GLAUCOMA VALVE
• Type of Device: GLAUCOMA SHUNT
• 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 ; 9094664304
• MDR Report Key: 7591867
• MDR Text Key: 111307477
• Report Number: 1000125279-2018-00011
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)180409(17)200409(10)D0218
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2020
• Device Model Number: FP7
• Device Catalogue Number: FP7
• Device Lot Number: D0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR