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Model Number UNKNOWN-V
Device Problem Complete Blockage (1094)
Patient Problem Bacterial Infection (1735)
Event Date 10/29/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
Marcelo galarza & volkan etus & fidel sosa & romina argañaraz &beatriz mantese & roberto gazzeri & christian garcia montoya & pedro de la rosa & antonio lópez guerrero & gerald chaban & ángel giménez & josé maría amigó. Flow ventricular catheters for shunted hydrocephalus: initial clinical results. Child's nervous system (2020). Doi: 10. 1007/s00381-020-04941-8 abstract background the non-homogenous flow of the cerebrospinal fluid within the ventricular catheter is one of the causative factors in shunt obstructions during the treatment of hydrocephalus. Previously, we studied the flow in ventricular catheters under the steady and pulsatile boundary conditions by means of computational fluid dynamics (cfd) in three-dimensional paradigms. Subsequently, several catheter designs with homogeneous flow patterns were developed out of which one prototype was chosen after a validation study. Objective to test the effectiveness of the flow ventricular catheter in a prospective, multicenter, comparative study. Methods eligible centers were three pediatric hospitals: two with sole adult practice and one a mixed pediatric-adult. Standard silicone material was used to develop a parametric cathetermodel with homogenous flow characteristics. The flow catheters were inserted in pediatric (n
30) and adult (n
10) patients with all types of hydrocephalus. Simultaneously, regular ventricular catheters were inserted in another 43 control patients in the participating centers. Catheter positioning was standardized according to the schaumann and thomale classification. Results all ventricular catheters had a cephalad grade i or ii positioning, and caudally, its extension had a peritoneal location. Programmable valves were utilized in 70% and antisiphon devices in 20% of the cases. Regular differential pressure valves were utilized in the remaining. No case of flow catheter obstruction was identified during a mean follow-up period of 2 years at the time of this writing. There were four catheter obstructions in the control cohort, all pediatric cases, during the first year. Shunt infections occurred in two cases in the control group, while there was one recurrent case of adult ventriculitis in the flow catheter group. Conclusions this prototype model represents the next generation of ventricular catheters with a homogeneous flow pattern. The flow catheter can be inserted safely in hydrocephalic patients, and this preliminary prospective comparative study showed a possible obstruction-free functionality. Reported events - in the control group, shunt infections, with klebsiella sp. And staphylococcus aureus respectively, occurred in two cases: one neonate and one adult with nph. Both cases were then treated accordingly with antibiotics, shunt removal, evd insertion and subsequent shunt revision after negative csf cultures. - one patient with posthemorrhagic hydrocephalus (sah) was implanted with a vp shunt the flow catheter. Subsequently, this patient developed fever spikes after 10 days and new csf cultures revealed persistence of the stenotrophomonas infection, and the entire shunt system, although functioning, was removed. After adequate antibiotic therapy confirmed by negative csf cultures, a new vp shunt system was inserted, this time with the standard ventricular catheter. This patient was later discharged home with family support and her latest imaging showed a controlled hydrocephalus. - in the control group, the ventricular catheter obstruction in the vp shunt system occurred in four pediatric cases. The shunt malfunctions occurred during the first year after surgery and were diagnosed by clinical and imaging signs of ventriculardilatation. In cases with obstructed ventricular catheter, all with occipital entry point and schaumann and thomale type i grade, the etiologies of the hydrocephalus included prematurity and congenital hydrocephalus. The obstruction of the vc happened between 4 and 6 months after insertion in two premature infants and, 12 to 14 months after insertion, in two cases with congenital hydrocephalus. All these patients required operative revision of the vp shunt system with replacement of the ventricular catheter. Thereafter, no further malfunctions of the vp shunt system were recorded.
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Manufacturer (Section D)
5290 california ave
irvine CA 92617
Manufacturer (Section G)
5290 california ave
irvine CA 92617
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key11232974
MDR Text Key229118556
Report Number2021898-2021-00026
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1