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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828804
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure of Implant (1924)
Event Date 12/06/2021
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
1 of 2 reports.Other mfg report number: 3013886523-2021-00565.A physician reported a certas valve was implanted via l-p shunt on (b)(6) 2021 with unknown setting.The valve was used with 823074 and the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).Shunt dysfunction occurred (unknown failure) and the valve and bactiseal peritoneal catheter were removed and replaced on (b)(6) 2021.A large amount of blood was found in the explanted valve.It is unknown if the patient experienced any signs and symptoms due to valve failure.
 
Manufacturer Narrative
The certas valve (id 828804) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; the valve casing was tainted brownish/red color.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, siphon guard 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 have been due to biological debris and protein build up interfering with the valve mechanism, but at the time of investigation no functional issues were noted.
 
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Brand Name
CERTAS INLIN VLV ONLY W/SPHNGD
Type of Device
CERTAS PLUS W/ SG
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 Key13077345
MDR Text Key282711263
Report Number3013886523-2021-00564
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,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number828804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
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
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