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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN CERTAS INLINE VLV; CERTAS PLUS

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INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN CERTAS INLINE VLV; CERTAS PLUS Back to Search Results
Catalog Number 828801
Device Problem Infusion or Flow Problem (2964)
Patient Problem Failure of Implant (1924)
Event Date 10/19/2021
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 physician reported the certas valve ( (b)(4)) was implanted into the patient via ventricular peritoneal shunt on unknown date with unknown setting.It was suspected that the tip of the ventricular catheter was obstructed and the flow of cerebrospinal fluid was poor.The valve was removed and replaced on (b)(6) 2021.Intraoperatively it was decided not to remove the ventricular catheter.The surgical time was extended more than 30 minutes.It is unknown if the patient experienced any signs or symptoms due to product failure.
 
Manufacturer Narrative
The certasa valve (828801) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 6.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was hydrated.The catheters were irrigated no occlusions noted.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation the no occlusion issues were noted with the valve.
 
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Brand Name
CODMAN CERTAS INLINE VLV
Type of Device
CERTAS PLUS
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ 
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ  
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key12739556
MDR Text Key279634046
Report Number3013886523-2021-00464
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K143111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/16/2021
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 Catalogue Number828801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2021
Initial Date FDA Received11/02/2021
Supplement Dates Manufacturer Received11/30/2021
Supplement Dates FDA Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexFemale
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