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

Catalog Number NS-9008

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

The reported valve was implanted to a patient via lp-shunt (doi and initial setting were unknown).It was reported that the surgeon found the lumber catheter was torn so that the revision surgery was performed on (b)(6) 2017 (part number and setting were unknown).No further information was provided by the hospital.

Manufacturer Narrative

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

Manufacturer Narrative

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 inside the valve mechanism, as well as needle holes in the needle chamber.The catheters were visually inspected no defects were noted.The position of the cam when valve was received was 100 mmh2o.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4) and programmer 82-3190 with serial (b)(4), the valve failed the test, the cam mechanism did not move during the programming process.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, leaked from the needle holes over the needle guard.The catheters were irrigated; no occlusion was 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 valve was then pressure tested at a 100 mmh20, the valve passed.The valve was dismantled and was examined under microscope at appropriate magnification: 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 ns9008, with lot crmbw5, conformed to the specifications when released to stock on the 12th november 2014.The root cause of the problem found during investigation 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.No problem was found with the 2 pieces of catheter that were returned.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 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6793809
• MDR Text Key: 82670827
• Report Number: 1226348-2017-10588
• 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: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: NS-9008
• Device Lot Number: CRMBW5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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