MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number NS-9008

Device Problems Partial Blockage (1065); No Flow (2991); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The valve was implanted to the patient via lp-shunt on (b)(6) 2017 for treatment of normal pressure hydrocephalus after intracranial tumor excision with setting 100mmh2o.After that, since improvement was not obtained, the pressure setting was attempted to change to low but it was not able to be changed.The shunt contrast was also blocked, and confirmed that it was not flow to the abdominal cavity, and the reduction of the ventricle was not proceeded.The revision surgery was not performed as vp.The patient has a primary disease (brain tumor).Csf protein: normal.The grasping the valve indwelling part was appropriate.There is no doubt of programmer failure and valve inversion.There was no suspicion of programmer failure and valve inversion.The flush was conducted.The pressure setting was confirmed by x-ray.And no further information was provided by the hospital.The product will be returned to your site.The valve was revised.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion o the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated udi: (b)(4).Device evaluation.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 100mmh2o.The valve was visually inspected: biological debris was noted inside the valve mechanism, as well as a liquid.The valve was hydrated.The valve was tested for programming with programmer (b)(4) with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test.The valve was leak tested, no leaks noted.The catheters were irrigated, no occlusions noted.The valve was reflux tested, the valve passed the test.The siphon guard was tested.The siphon guard passed the test.The valve was dried.The siphon guard was removed.The valve was pressure tested, the valve failed the test.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 ruby ball, on the cam mechanism, and on the base plate.Review of the history device records confirmed the valve product code ns9008, with lot 116575, conformed to the specifications when released to stock in 9th february 2017.The root cause of the problem found during investigation is due to the biological debris found on the spring, on the spring pillar, on the ruby ball, on the seat of ruby ball, on the cam mechanism, and on the base plate.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
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7176614
• MDR Text Key: 96811250
• Report Number: 1226348-2018-10040
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: NS-9008
• Device Lot Number: 116575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention