MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. VALVE PEDIATRIQUE P CSD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 0147CSD

Device Problems Partial Blockage (1065); Device Operational Issue (2914); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Valve mis-function female patient per (b)(6).Valve blocked, can not be set in situ: it was impossible to modify the pressure.Valve was removed and replaced.No patient consequences reported.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected udi: device was made prior to compliance date, (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; no defects were noted.The position of the cam when valve was received was 150 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.The valve was reflux tested.The valve failed the test.The valve was dried.The valve was then pressure tested at a 150 mmh20, the valve failed.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the ruby ball, on the seat of the ruby ball, and on the cam mechanism.The cam magnets were also controlled.The magnets failed.The magnets polarity was controlled failed all magnets were on ( - ).Review of the history device records for the valve product code 0147csd with lot chmbn1 conformed to the specifications when released to stock on the 29th october 2007.The abnormal polarization of the valve was probably caused by an exposition of a too strong magnetic field.Further details in chpv mri testing conducted.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: VALVE PEDIATRIQUE P CSD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6974210
• MDR Text Key: 90125223
• Report Number: 1226348-2017-10789
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 0147CSD
• Device Lot Number: CHMBN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2007
• 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
• Patient Age: 37 YR