MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE INLINE UNIT (INTEGRAL CON); SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3844

Device Problem Use of Device Problem (1670)

Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Vomiting (2144)

Event Date 03/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

The device was implanted via v-p shunt to a patient with congenital hydrocephalus and dandy-walker syndrome on (b)(6) 2010.The initial pressure setting was 80mmh2o.After that, the setting was changed to 110mmh2o on (b)(6) 2011, 130mmh2o on (b)(6) 2012, and 150mmh2o on (b)(6) 2012.After the setting change to 170mmh2o on (b)(6) 2012, any further change became impossible; however, no signs of dysfunctionality was found with the device at the follow-up visit.On (b)(6) 2016, the patient had a headache and vomiting and visited the hospital.Ct scanning showed that although the ventricules of the patient's brain became a bit smaller, there was no problem with the valve.On (b)(6) 2016, the patient visited the hospital again due to a postural headache and vomiting on standing, and intracranial hypotension (<30mmh2o) was confirmed by tapping.Since the valve was found dysfunctional, the device was replaced with (b)(4) set at 170mmh2o on the same day.The patient's condition was improved after the revision.

Manufacturer Narrative

Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The position of the cam when valve was received was 200mmh2o.The valve was hydrated for about 44 hours.The valve was visually inspected: the base of the needle chamber was missing as well as cuts/tears in the silicone housing.The valve was tested for programming.With programmer 82-3126 with serial number (b)(4) and programmer 82-3190 with serial number (b)(4), the valve failed the test, the cam mechanism did not move during the programming process.The valve could not be flushed due to the damaged silicone housing.The valve could not be reflux tested due to the damaged silicone housing.The valve could not be leak tested, due to the damaged silicone housing.The valve could not be pressure tested at 170mmh2o, due to the damaged silicone housing.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, on the cam mechanism pillar and on the base plate.Review of the history device records confirmed the valve product code 82-3844, with lot cklc64, conformed to the specifications when released to stock in 20th october 2009.The root cause of the problem for the programming issue is due to biological debris found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, on the cam mechanism pillar and on the base plate.The root cause for the missing needle guard base plate could not be determined.The root cause for the cuts/tears in the silicone housing could be due to a sharp or pointed object coming into contact with the silicone.As noted in the ifu silicone has a low cut / tear resistance.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.

• Brand Name: HAKIM VALVE INLINE UNIT (INTEGRAL CON)
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5574161
• MDR Text Key: 42557733
• Report Number: 1226348-2016-10293
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974739
• Number of Events Reported: 1
• 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 Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-3844
• Device Lot Number: CKLC64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR