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

Catalog Number NS9008

Device Problem Obstruction of Flow (2423)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the hakim programmable valve separated from the lumbar catheter and was later blocked.The patient had neurologic symptoms and the device has been revised.The patient was transferred to another hospital, but came to have a consultation because of headache and vomiting.Then it was confirmed by an image that the lumbar catheter was disconnected to the valve.Therefore, the lumber catheter was re-connected with local anesthetic.The pressure setting was at 100.The patient continued to have neurologic headache, so imaging was done.Shunt occlusion was suspected because the contrast media did not flow to the abdominal cavity side.The revision surgery was performed and the valve was replaced with another similar device.The pressure setting is at 50 for now and the patient outcome is fine.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

Udi : (b)(4).The device was returned for evaluation.The position of the cam when valve was received was 30mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was tested for programming and passed the test.The valve was flushed; no occlusion was noted.He valve was leak tested and only leaked from the needle holes in the needle chamber.The catheter was irrigated, no occlusions noted.The valve was reflux tested; no issues found.The siphon guard was tested and passed.The siphon guard was removed.The valve was then pressure tested; the valve passed the test.A review of manufacturing records found the device conformed to specification when released to stock.No root cause could be determined; as no functional problem was noted with the valve.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN HAKIM PROGRAMMABLE 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
• MDR Report Key: 7645579
• MDR Text Key: 112577119
• Report Number: 1226348-2018-10448
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: NS9008
• Device Lot Number: 133117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR