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

Catalog Number 82-3110

Device Problems Partial Blockage (1065); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

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.Doi and initial setting were unknown.It was reported that the revision surgery was performed due to the blockage of the abdominal cavity catheter.(*the manufacturer of abdominal cavity catheter was being confirmed, there was a possibility of medotro, bioglide.).Furthermore the white marker was dropped off.It was unknown where is the white marker.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

Updated udi : (b)(4).The valve was returned for evaluation.The valve was visually inspected; white debris was noted stuck to the silicone housing distal end, a crack and bump mark in the valve casing, x ray dot dislodged, needle holes over the needle guard, cut/tear in silicone housing on the side of the valve, and the spring was missing from the outlet connector.The position of the cam when valve was received was 150mmh2o.The valve was tested for programming and passed the test.The valve was flushed; no issues were noted.The valve was leak tested and leaked from the tear/cut in the silicone housing.The valve was reflux tested and failed the test.The valve was then pressure tested and failed the test.The valve was dismantled and was examined under microscope at appropriate magnification: when dismantling the valve, the stator came away from the base plate.Corrosion was noted on the stator.A crack and a bump mark was noted in the valve casing.Biological debris was found on the silicone housing.A review of manufacturing records found no discrepancies when the device was released to stock.The root cause for the crack and bump mark in the valve casing was likely due to the valve receiving a hard knock.The root cause for the outlet spring, is likely due to the valve receiving a hard knock but this could not be conclusively determined.Previous investigation of stator dislodgement of chpv concluded that several factors may contribute to the stator dislodgement.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.Galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.Trends will be monitored for this and similar complaints.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE W/PRECHAMBER
• 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: 7303445
• MDR Text Key: 101237413
• Report Number: 1226348-2018-10194
• 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: company representative,foreig
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2006
• Device Catalogue Number: 82-3110
• Device Lot Number: 913236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention