MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSV II

Catalog Number 909708S

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.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 after implantation, the ventricular catheter of the osv ii (product id 909708s) was blocked, over-drainage occurred and it was slit, making it necessary to replace it.There was increased surgery time, but the amount of time is unknown.

Manufacturer Narrative

An evaluation of the actual osv ii valve could not be performed because the device was discarded at the facility.However, lot number was provided ; therefore, device history records were reviewed which revealed no anomalies that could explain the reported event.Failure analysis: the surgeon expressed concerns with the osv ii that he knows from a long time and is wondering whether the valve operating characteristics have changed: he feels that the ruby part may remain wedged with the membrane (diaphragm).A review of the manufacturing process since 2016 revealed no material change, no design change, no process change, no components supplier / design change : ruby pin and seat and the silicone elastomer diaphragm are unchanged: valve operating characteristics have not changed.Root cause - without actual device to analyze, complaints are unverifiable and exact root cause could not be determined.Overdrainage is a known, patient-related complication of valve therapy, as stated in the product instructions for use.Hydrocephalus shunt systems obstruction is known to be correlated to overdrainage: overdrainage leads to slit ventricle, blocking the ventricular catheter: then residues (from plexus choroid) can move along the shunt and block the valve mechanism.No further investigation nor corrective action is deemed required.

Event Description

N/a.

• Brand Name: OSV II
• Type of Device: OSV II
• 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: 11396554
• MDR Text Key: 234219085
• Report Number: 9612007-2021-00016
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K971799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Catalogue Number: 909708S
• Device Lot Number: 0201173
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1