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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 Loss of consciousness (2418)
Event Date 12/14/2021
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 a certas valve was implanted via l-p shunt on (b)(6) 2021, with setting 7.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).On (b)(6) 2021, the setting pressure was changed from 7 to 6.On an unknown day, the physician tried to change the set pressure because the patient's consciousness was not clear, but the set pressure could not be changed.On (b)(6), the physician tried to puncture the valve but couldn¿t, and the physician couldn't get the cerebrospinal fluid.It was suspected shunt dysfunction, therefore, the valve was removed and replaced on (b)(6) 2021.
 
Event Description
N/a.
 
Manufacturer Narrative
The certas valve (id (b)(4) was returned for evaluation.Device history record (dhr) - the product code 828806 with lot 5355139 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 7.The valve was visually inspected, small needle hole noted in the underside of the needle chamber, small cut in ventricular catheter near the suture was noted.The valve was hydrated.The valve was leak tested only leaked from the small needle hole in the underside of the needle chamber and leaked from the cut in the catheter.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 root cause for the cut in the catheter is probably due to a sharp or pointed object coming into contact with the catheter, as noted in the ifu silicone has a low cut/tear resistance.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 programing issues were noted.
 
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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
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 Key13117030
MDR Text Key282954502
Report Number3013886523-2021-00574
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number828806
Device Lot Number5355139
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/25/2022
Supplement Dates FDA Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2021
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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