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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828806
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cerebral Ventriculomeglia (2133)
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 a codman certas plus programmable in-line valve was implanted in a patient after a subarachnoid hemorrhage via a lumbar peritoneal shunt on (b)(6) 2021 with an initial setting of 4.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).Ventricular enlargement was suspected due to gait disturbance, and when the set pressure was changed to setting 2 on (b)(6) 2021 the symptoms did not change.Due to patient disorientation on (b)(6) 2021 a brain mri was performed and ventricular enlargement was confirmed.The pressure was changed to a setting of 1.Ventricular enlargement improved.Due to patient disorientation on (b)(6) 2021 a brain mri was performed and ventricular enlargement was confirmed.Flushing was performed without an improvement in clinical symptoms.The patient was taken to the operating room for a shunt revision and the valve was removed and replaced on (b)(6) 2021.The patient is in the follow up.No further information was provided by hospital.
 
Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The valve was returned for evaluation: failure analysis: the position of the cam when valve was received was at setting 1.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was hydrated per internal process.The valve was leak tested and only leak from the needle holes in the needle chamber.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 be due to biological debris and protein build up interfering with the valve, at the time of investigation the no functional issues were noted.
 
Event Description
N/a.
 
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Brand Name
CERTAS INLIN VLV SPHN/UNIT CAT
Type of Device
CERTAS PLUS W/ SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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MDR Report Key12104847
MDR Text Key263826051
Report Number3013886523-2021-00278
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 company representative,health
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number828806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Initial Date Manufacturer Received 06/14/2021
Initial Date FDA Received07/01/2021
Supplement Dates Manufacturer Received09/14/2021
Supplement Dates FDA Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
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