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

Catalog Number NS9008

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(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) 2016 with setting 160 mmh2o.It was reported that the pressures setting was not able to be changed when the surgeon tried to change the setting due to the hydrencephalus become advanced.It was tried on (b)(6) 2017.A revision surgery was performed on (b)(6) 2017 via vp-shunt.The product will be returned to your site.The patient is female.Csf protein: normal.Original disease: subarachnoid hemorrhage.

Manufacturer Narrative

It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no product or 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 the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was incorrectly reported in additional mfr narrative that the device had not been made available for evaluation.The device has been returned and will be evaluated.Upon completion of the investigation a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The valve was visually inspected; biological debris was noted inside the valve.The position of the cam when valve was received was 16mmh2o.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.The valve was leak tested, no leaks noted.The catheter was 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 then 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 the ruby ball, and on the base plate.Review of the history device records for the valve product code ns9008 with lot cvccpf conformed to the specifications when released to stock on the 24th march 2016.The root cause of the problem reported by the customer is due to the biological debris found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7135097
• MDR Text Key: 95392239
• Report Number: 1226348-2017-10996
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: NS9008
• Device Lot Number: CVCCPF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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: 65 YR