MAUDE Adverse Event Report: HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3100

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product code.Upon completion of the investigation, a follow up report will be filed.

Event Description

As reported by the ous territory manager, after seven years, a hakim valve could not change settings after an mri.Valve was explanted.Additional information requested.

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.The valve was visually inspected; biological debris was noted, as well as needle holes in the silicone housing.The position of the cam when valve was received was 80mmh2o.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial number (b)(4) and programmer 82-3190 with serial number (b)(4), the valve failed the test, the cam mechanism did not move during the programming process.The valve was flushed, passed.The valve was leak tested, leaked from the needle holes in the silicone housing.The valve was reflux tested, the valve failed the test.The valve was dried.The valve was pressure tested at 80mmh2o, the valve failed the test.The valve was dismantled and was examined under microscope at appropriate magnification: a scratch mark was noted in the valve casing.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.The cam magnets were also controlled.The magnets passed.Review of the history device records for the valve product code 82-3100, with lot clbb4z conformed to the specifications when released to stock on the 2nd february 2010.The root cause of the bump mark found in the valve casing is due to the valve receiving some form of impact.The root cause of the problem reported by the customer 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.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 WITH PRECHAMBER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7134727
• MDR Text Key: 95379353
• Report Number: 1226348-2017-10994
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• 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: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 82-3100
• Device Lot Number: CLBB4Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2010
• 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