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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG Back to Search Results
Catalog Number 823162
Device Problem Obstruction of Flow (2423)
Patient Problems Failure of Implant (1924); 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
1 of 2 reports.Other mfg report number: 3013886523-2021-00300.A physician reported a hakim programmable in-line valve was implanted in a patient via ventricular peritoneal shunt on (b)(6) 2021 with an unknown initial setting.The valve was used with catheter 823072 (serial; unknown).The patient¿s condition was reported as stable one week after the operation.Ventricular enlargement was observed radiographically on (b)(6) 2021.No improvement in the ventricular enlargement was seen after changing the shunt valve pressure.There were no clinical symptoms of hydrocephalus other than the ventricular enlargement.The shunt was diagnosed as clogged by pumping.The patient was taken to the operating room for a shunt and catheter revision surgery on (b)(6) 2021.The patient is in ¿good condition.¿ no further information was provided by the hospital.
 
Manufacturer Narrative
The valve was returned for evaluation.Device history record (dhr) - lot 4818850 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; some biological debris was noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The valve passed the test for reflux, programming, occlusion, leaks, reflux, siphon guard and pressure.Root cause: 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 ¿the shunt was diagnosed as clogged by pumping¿ 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 flow issues were noted with the valve.
 
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Brand Name
PROG VALVE INLINE W SG
Type of Device
CHPV WITH SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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MDR Report Key12148120
MDR Text Key267670895
Report Number3013886523-2021-00299
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K041296
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number823162
Device Lot Number4818850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Date Manufacturer Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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