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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA INTEGRA DP PEDIATRIC BURR HOLE SYSTEM DP VALVE

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INTEGRA NEUROSCICENCS IMPLANTS SA INTEGRA DP PEDIATRIC BURR HOLE SYSTEM DP VALVE Back to Search Results
Catalog Number 908142
Device Problems Flushing Problem (1252); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2016
Event Type  malfunction  
Event Description
A report was received for the 908142 dp pediatric burr hole system. On (b)(6) 2016, a (b)(6) female patient, was undergoing a vp shunt placement with stealth for hydrocephalus. She did not sustain any injury and had a good outcome. The report stated that after the shunt was placed and connected to the ventricular catheter, the system would not flush per the normal process. According to the surgeon, it appeared that the valve was not working properly. A new system was connected to the existing ventricular catheter and the system worked fine. The incident delayed surgery by 20 minutes.
 
Manufacturer Narrative
Integra has completed their internal investigation on 16 aug 2016. The product was not returned for evaluation thus the complaint is unverifiable. The device history records of ref 908142 lot 0192731 were reviewed and did not reveal any anomaly. The batch was manufactured in december 2015 and included (b)(4) products. No similar complaint was received for a product from this batch. Upon review of integra¿s complaint system from january 2013 - june 21, 2016, one (1) similar complaint for an integra dp valve has been reported. No trend is observed. Conclusion: without actual device to investigate, the root cause of the reported problem of flush could not be determined. No further investigation nor corrective action is deemed required.
 
Manufacturer Narrative
The device was returned and integra has completed their internal investigation on 10 oct 2016. The investigation included: methods: -evaluation of actual device, -review of device history records, -review of complaint history. Results: evaluation of device: the valve was blocked, no flush with water was possible. Air aspiration using a syringe initially showed resistance, then resistance disappeared and the valve was unblocked. After decontamination, the valve was pressure/flow tested and found within specifications. The complaint is verified, the received valve could not be flushed. The device history records of ref 908142 lot 0192731 were reviewed and did not reveal any anomaly. Device history records of this valve sn (b)(4) showed this valve was tested within specifications at time of manufacturing. The batch was manufactured in december 2015 and included 21 products. No similar complaint was received for a product from this batch upon review of integra¿s complaint system from january 2013 - june 21, 2016, one (1) similar complaint for an integra dp valve has been reported ((b)(4) in january 2015). No trend is observed. Conclusion: the valve investigation could not determine the exact cause of the blockage. It is possible that some debris released during implantation procedure was blocking the valve mechanism. The complaint rate for such event is low ((b)(4)) and the integra dp valves are marketed since over 30 years: no further investigation nor corrective action is deemed required.
 
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Brand NameINTEGRA DP PEDIATRIC BURR HOLE SYSTEM
Type of DeviceDP VALVE
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
bina patel
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key5727996
MDR Text Key48501842
Report Number9612007-2016-00013
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K152897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number908142
Device Lot Number0192731
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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