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

Catalog Number 82-3832

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During v-p shunt implantation, a foreign matter intruded into the valve and could not be removed by pumping.Another valve was used to complete the case, and there were no adverse consequences to a patient.

Manufacturer Narrative

Upon completion of the investigation it was noted that the position of the cam when valve was received was 110mmh2o.The valve was visually inspected: and confirmed the debris inside the valve as reported by the customer.Review of the history device records confirmed the valve product code 82-3832, with lot ctgbrr, conformed to the specifications when released to stock on the 30th june 2015.The root cause of the problem reported by the customer could be due to flushing valve with fluid in which cotton gauze or other lint-releasing material has been soaked, this however could not be confirmed.As noted in the ifu do not fill, flush, or pump the valve with fluid in which cotton, gauze, or other lint-releasing material has been soaked.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: PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5566957
• MDR Text Key: 42385642
• Report Number: 1226348-2016-10286
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992173
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 82-3832
• Device Lot Number: CTGBRR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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