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

Catalog Number 82-3100

Device Problems Partial Blockage (1065); Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- unknown.It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

The valve was implanted to the patient via vp-shunt.Doi and initial setting were unknown.It was reported that the pressures setting was not able to be changed at the outpatient department.Furthermore there was a suspicion of blocking the valve when the contrast was conducted.Therefore the valve and the abdominal catheter were removed and the revision surgery was performed on (b)(6) 2018.The surgeon commented that the implant period was long, so it was suspected that there are some causes.The patient¿s information was unknown.Original disease: unknown.Csf protein: unknown.It was suspected of blood and debris contamination in the cerebrospinal fluid.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

Updated udi -- (b)(4).The valve was returned for evaluation.The valve was visually inspected; tears / cuts were noted in the silicone housing, needle holes over the needle guard, as well as biological debris were noted.The position of the cam when valve was received was 30mmh2o.The valve was tested for programming and failed the test; the cam mechanism did not move during the programming process.The valve was flushed; an occlusion was noted at the ruby ball.The silicone was cut just after the cam mechanism; the mechanism was unstuck.The valve was retested for programming and again failed the test; the cam mechanism did not move during the programming process.The valve was dismantled and was examined under microscope at appropriate magnification.Biological debris was found on the spring on the ruby ball, on the cam mechanism, on the base plate and in the valve casing.The cam magnets were tested, passed.A review of manufacturing records found that the device conformed to specification when released to stock.The root cause of the problem reported by the customer is due to the biological debris found on the spring on the ruby ball, on the cam mechanism, on the base plate and in the valve casing.The root cause for the tear/cut in the silicone housing is likely due to a handling issue.As noted in the ifu silicone has a low tear / cut resistance.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

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

• Brand Name: HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
• 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: 7363988
• MDR Text Key: 103266221
• Report Number: 1226348-2018-10229
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 5/28/2018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 82-3100
• Device Lot Number: CPFCFG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 05/28/2018
• Supplement Dates FDA Received: 04/10/2018; 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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