MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII, CONNECTOR W/O ANTECHAMBER; N/A

Catalog Number 909708S

Device Problems Partial Blockage (1065); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The device was explanted from the patient as it did not work.Additional information has been requested.

Manufacturer Narrative

Additional information received 21dec2017: the drainage was blocked.There was no other information provided.

Manufacturer Narrative

Investigation completed 17jan2018.Patency testing of the received osv ii valve did not reveal any anomaly.Pressure/flow testing showed the valve pressure/flow characteristics are below the specification.The valve modulus was then removed from its silicone elastomer housing and further microscopic examination revealed residues in the valve mechanism, on the pin and seat.No other anomaly was observed.The device history records of ref 909708s lot number 196598, serial number (b)(4) were reviewed and did not reveal any anomaly.The batch was manufactured in july 2016 and included 13 valves.No similar complaint was received for a product from this batch.The complaint is verified; the received valve is out of specification because of the presence of residue in the valve mechanism.These residue may explain the reported underdrainage (the valve was manufactured in 2016, duration of implantation is unknown).

• Brand Name: OSVII, CONNECTOR W/O ANTECHAMBER
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7100278
• MDR Text Key: 95738251
• Report Number: 9612007-2017-00031
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 909708S
• Device Lot Number: 196598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1