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

Catalog Number 82-3182

Device Problem Device Operational Issue (2914)

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

Shunt implanted and found not working.Per affiliate, both valve and catheter were replaced.

Manufacturer Narrative

(b)(4).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 30 mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted, and the proximal connector was slightly bent.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4), the valve passed the test.The valve was flushed, the valve failed the test an occlusion was noted.The valve could not be leak tested, due to the blockage.The valve could not be reflux tested due to the blockage.The siphon guard could not be tested due to the blockage.The valve was dried.The siphon guard was removed.The valve could not be pressure tested, due to the blockage.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, and on the base plate.Review of the history device records confirmed the valve product code 82-3182, with lot cvkb3c conformed to the specifications when released to stock in 27th september 2016.Review of the history device records confirmed the bactiseal catheter product code 82-3072, with lot 128451, conformed to the specifications when released to stock in 4th april 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 the ruby ball, on the cam mechanism, and on the base plate.The root cause for the slightly bent proximal connector is probably due to user error, this however could not be determined.No defects were note with the bactiseal catheter.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 PROGRAMMABLE VALVE, RT ANGLE W/SIPHONGUARD
• 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: 7110222
• MDR Text Key: 94576150
• Report Number: 1226348-2017-10975
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 82-3182
• Device Lot Number: CVKB3C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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