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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3832
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 03/28/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
V-p valve was found with precipitation , changed another one to complete. The patient is (b)(6), female and (b)(6). Preoperative ct showed the patient with ventricular dilatation. And the patient did ventriculoperitoneal shunt operation on (b)(6) 2017. Shunt tube was inserted into 5 cm, v-p shunt valve pressure was adjusted to 150 mm h2o. The ct ventricle was significantly expanded after operation, and there was no significant improvement in consciousness. Two days after operation, the pressure was adjusted to 120, and 4 days after operation, the pressure was adjusted to 100. There was no significant improvement in consciousness either. And then on (b)(6) 2017, the patient had ventriculoperitoneal shunt exploration operation, it found the v-p shunt valve had precipitate inside which is not clear. Changed another one to complete the second operation. The patient is still in the observation and patient¿s consciousness become a little better.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation, it was noted that the images were taken of the valve ¿as received¿ and are attached. The valve was visually inspected; some biological debris was noted at the base of the needle chamber. The position of the cam when valve was received was 100mmh2o. The valve was hydrated. The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test. The valve was flushed, the valve passed the test no occlusion was noted. The valve was leak tested, no leaks noted. The valve was reflux tested. The valve passed the test. The siphon guard was tested. The valve passed the test. The valve was dried. The siphon guard was removed. The valve was then pressure tested, the valve passed the test. Review of the history device records confirmed the valve product code 82-3832, with lot cvdcpl, conformed to the specifications when released to stock on the 28th april 2016. Review of the history device records confirmed the bactiseal catheter product code 82-3072, with lot 1106466, conformed to the specifications when released to stock on the 9th january 2017. No root cause could be determined, as the problem reported by the customer could not be duplicated. If the bactiseal catheter is returned in the future the complaint will be reopened and the catheter investigated. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
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Brand NamePROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6538051
MDR Text Key74209007
Report Number1226348-2017-10298
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number82-3832
Device Lot NumberCVDCPL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2016
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: 05/02/2017 Patient Sequence Number: 1
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