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

Catalog Number 82-3146

Device Problems Sticking (1597); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 12/10/2017

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 vp-shunt about (b)(6) 2013 with setting 120mmh2o.It was reported that the surgeon tried to change the pressure setting with a programmer but it was not able to be changed when the patient visited the hospital as outpatient department.The size of ventricle increased and the symptom of hydrocephalus did not improved.The revision surgery was performed on (b)(6) 2017.The valve was replaced with new one (same product code with 70mmh2o.The patient was (b)(6) male, and the original disease is inph.The patient's condition is stable.The setting of another patient's valve could be changed with using same programmer, so it was suspected that the valve cam got stuck.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.The product will be returned to your site.

Manufacturer Narrative

The device has been returned for evaluation.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; needle hole in the needle chamber was noted.The position of the cam when valve was received was 90 mmh2o.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4) and programmer 82-3190 with serial (b)(4), the valve failed the test, the cam mechanism did not move during the programming process.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, only leaked from the needle holes.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 at a 90 mmh20, the valve failed.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the on the cam mechanism.The cam magnets were also controlled.The magnets failed.The magnets polarity was controlled failed all magnets were on (-).Review of the history device records for the valve, product code 82-3146 with lot cnkb27 showed an nc report when released to stock on the 1st october 2012, the nc report issue had no link to this complaint.The root cause could be due to the biological debris found on the cam mechanism, this however could not be determined.The abnormal polarization of the valve was probably caused by an exposition of a too strong magnetic field, this however could not be determined.Further details in chpv mri testing conducted.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, RIGHT ANGLE RES. UNITIZED SG
• 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: 7154682
• MDR Text Key: 96048843
• Report Number: 1226348-2017-11014
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992173
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 82-3146
• Device Lot Number: CNKB27
• 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: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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: 75 YR