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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROG VALVE RIGHT ANGLE; CHPV
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PROG VALVE RIGHT ANGLE; CHPV Back to Search Results
Catalog Number 823184
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problems Headache (1880); Vomiting (2144)
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 sales representative reported: "per history, the patient had undergone a revision surgery with codman programmable shunt implantation because she was over-draining at medium pressure fixed shunt.Despite raising the pressure till 200mm of h2o, she was still having over draining and there was no clinical change which she was having before chpv implant.On 19th january, her shunt was ligated but within 12 hours she returned back with headache & vomiting, due to severe issue of hydrocephalus.On 20th january, doctor tried to manage with attaching siphon guard to regulate the draining but it was not helpful; which he followed by trying to create mechanical obstruction using clips to reduce the flow, but it was also not helpful as eventually it blocked completely.Patient is showing some improvements in the flow control after shunt replacement.".
 
Event Description
N/a.
 
Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim valve was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The possible root causes for "issues in regulating the pressure, over draining" could be due to "blockage due to build up of protein".
 
Manufacturer Narrative
The hakim valve was returned for evaluation.Device history record (dhr): the product code 82-3184 with, serial number pbd125, conformed to the specifications when released to stock.Failure analysis: the valve was visually inspected; a lot of needle holes in the needle chamber were noted small cuts/tears due to too many needle holes, as well as needle marks on the outside edge of the needle chamber silicone damaged.The position of the cam when valve was received was 170mmh2o.The valve was hydrated.The valve was flushed and failed leaked from the many needle holes in the needle chamber.The valve was leak and pressure tested and failed.The valve passed the test for programming and reflux.The possible root cause for the over drainage issue reported by the customer, was due to the needle holes/cut/tear in the silicone housing.The root cause for the needle hole/ cut/tear in the silicone housing noted during the investigation, is probably due to wrong handling, as noted in the ifu: to inhibit coring of the reservoir cap use a huber type needle (24- or 26-gauge) also noted in the ifu: silicone has a low cut/tear resistance.Do not use sharp instruments when handling the silicone valve or catheter, use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.
 
Event Description
N/a.
 
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Brand Name
PROG VALVE RIGHT ANGLE
Type of Device
CHPV
MDR Report Key11625088
MDR Text Key244169376
Report Number3013886523-2021-00158
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number823184
Device Lot NumberPBD125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Date Manufacturer Received10/15/2021
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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