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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG Back to Search Results
Catalog Number NS9008
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebral Ventriculomeglia (2133); Ambulation Difficulties (2544); Dementia (4405)
Event Date 02/15/2022
Event Type  Injury  
Event Description
A physician reported a hakim valve was implanted in a (b)(6) male patient due to inph (idiopathic normal pressure hydrocephalus) via l-p shunt in (b)(6) 2015 with unknown setting. The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). In (b)(6) 2022, the patient visited the hospital because of gait disturbance and some dementia. Shunt imaging was performed, and ventricular enlargement was observed. The set pressure was changed, but the symptoms did not improve. The valve was removed and replaced on (b)(6), 2022.
 
Manufacturer Narrative
The hakim valve ((b)(4)) was returned for evaluation. Device history record (dhr) - the product code (b)(4) with lot crpblb, conformed to the specifications when released to stock. Failure analysis - the valve was visually inspected; needle holes in the needle chamber were noted. The position of the cam when valve was received was 90mmh2o. The valve was hydrated. The catheter was 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, 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 mechanism, at the time of investigation no functional issues were noted.
 
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Brand NameSPECIAL DEVICE UNITIZED PROGRA
Type of DeviceCHPV WITH 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 Key13971693
MDR Text Key289783832
Report Number3013886523-2022-00125
Device Sequence Number1
Product Code JXG
UDI-Device Identifier10886704073161
UDI-Public(01)10886704073161(17)191231(10)CRPBLB
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberNS9008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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