MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA INTEGRA NPH LOW FLOW VALVE

Catalog Number 909512

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

An integra nph low flow valve (909512) with blood was returned to our manufacturing site with another complaint.No additional information was provided by the facility; however, we suspect that the presence of blood on the returned valve is indicative that the valve was explanted from a patient.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The nph low flow valve (909512) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.Failure analysis - valve unit was received with distal catheter cut.Fluid and blood were present in the valve.Patency test with air revealed no anomaly.Visual inspection noted a small tear of the valve sole at the inlet connector level, that did not lead to leakage.The valve was pressure/flow tested and found out of specifications: valve underdrains.The valve modulus was removed from its silicone elastomer housing and opened: inspection under magnification showed whitish residues (looking like organic residues) on the diaphragm and around the pin.Root cause -the complaint is verified, the valve as received was out of specifications because of residues impairing the valve mechanism.Each valve is pressure/flow tested at the end of its manufacturing process and valve sn 956864 was tested within specification as shown on the device history records.Valve underdrainage is a known, patient-related complications of valve therapy, as stated in the product instructions for use (ifu).With the available information, no further investigation nor corrective action is deemed required.

• Brand Name: INTEGRA NPH LOW FLOW VALVE
• Type of Device: NPH LOW FLOW VALVE
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• MDR Report Key: 12271107
• MDR Text Key: 265763857
• Report Number: 9612007-2021-00030
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K140722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Catalogue Number: 909512
• Device Lot Number: 208843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1