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 Flushing Problem (1252); Failure to Prime (1492)

Patient Problem No Information (3190)

Event Date 10/24/2016

Event Type  malfunction  

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 110mmh2o.The valve was hydrated for 24 hours.The valve was visually inspected: no defects were noted.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The catheter was irrigated, no occlusions were noted.The valve was reflux tested.The valve passed the test.The siphon guard was tested, the valve passed the test.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 cvhbpc, conformed to the specifications when released to stock in 12th july 2016.No root cause could be determined, as the problem reported by the customer could not be duplicated, as both the valves functioned.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.

Event Description

During the procedure, the clinician while performing the pre-implantation check noticed that the product could not be primed/flushed.Then he opened a second valve which likewise the first one could not be primed/flushed.

• 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 case postale; le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6138119
• MDR Text Key: 61244310
• Report Number: 1226348-2016-10821
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 82-3162
• Device Lot Number: CVHBCP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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