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

Catalog Number 909500

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2021

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

A facility reported that the integra nph low flow valve (909500) did not work and resulted in an unspecified revision procedure.Additional information has been requested.

Manufacturer Narrative

The nph low flow valve (909500) 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 - visual inspection revealed blood spots in the antechamber.No other anomaly was noted.Patency test with air revealed no obstruction.The valve was pressure/flow tested and found functional, within specifications.Root cause - the complaint was not verified by the valve investigation, the exact root cause of the patient clinical signs leading to explant the valve could not be determined.Since the valve was found within specifications, it is possible the valve specifications did not suit patient¿s drainage needs, or the valve was obstructed by a small residue (related to surgical technique, by blood/debris introduced in the shunt at insertion time if obstruction occurred early after implantation, or related to patient physiological condition, if obstruction occurred later), impairing the valve mechanism, and this residue was dislodged by further valve manipulations (explantation, transportation, decontamination).Since the received valve was found within specifications, 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: 12132721
• MDR Text Key: 260436176
• Report Number: 9612007-2021-00028
• 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?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Catalogue Number: 909500
• Device Lot Number: 0209006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1