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

Catalog Number 82-3162

Device Problems Occlusion Within Device (1423); Torn Material (3024)

Patient Problem Hydrocephalus (3272)

Event Date 12/12/2017

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 on (b)(6) 2017 with setting 100 mm h2o.It was reported that suspected valve occlusion.The revision surgery was performed with chpv + sg as a child (at this time only the valve was replaced).After the surgery, the patient¿s condition was not improved.The surgery was ineffective, respiration stops, the symptoms of hydrocephalus deteriorate.It was correspond with outside drainage etc.It was suspected valve occlusion again, and the revision surgery was performed on (b)(6) 2017.When trying to check whether it was not occluded at the time of removal, and it was found that there was a leak from the point between the variable part and the sg, and was also torn.It was unknown that it had been torn since valve was placed or at the time of removal.The surgeon concerned about the occlusion, and occlusion low-pressure abdominal catheter (not a codman product) and reservoir were placed and a valve was not placed.The surgeon want to the investigate which has there been a valve occlusion.(especially the sg part) and the torn was from the inside or outside.The patient¿s initial was (b)(6) female.She has the original disease.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 and are attached.The position of the cam when valve was received was 30 mmh2o.The valve was visually inspected: a tear/cut was noted in the silicone housing on the underside between the valve mechanism and the siphon guard.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 passed the test no occlusion was noted but leaked from the tear/cut in the silicone housing.The valve was leak tested.Leaked from the tear/cut in the silicone housing.The valve could not be reflux tested, due to the damaged silicone housing.The siphon guard could not be tested, due to the damaged silicone housing.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3162, with lot cvcbmg conformed to the specifications when released to stock in 8th march 2016.The root cause for the tear/cut in the silicone housing is probably due to the user, this however could not be determined.As noted in the ifu silicone has a low tear / cut resistance.Per hhe, it has been concluded that silicone housing tears are not design related, in order for the housing tear to occur the user has to compromise the silicone through a nick or tear in order for the event to occur.Validation testing demonstrates a robust design.Testing has shown that if the silicone housing has been compromised, a housing tear is likely to occur.If the 2nd valve is returned in the future this complaint we be reopened and investigated.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 INLINE PROGRAMMABLE VALVE 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: 7164154
• MDR Text Key: 96365090
• Report Number: 1226348-2018-10016
• 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: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 82-3162
• Device Lot Number: CVCBMG
• 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: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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: 6 YR