MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÀRL/ DEPUY INC. CODMAN CERTAS SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 82-8804PL

Device Problem Kinked (1339)

Patient Problem No Code Available (3191)

Event Date 06/20/2017

Event Type  malfunction  

Event Description

The patient returned to the or for evaluation of a shunt failure following laparoscopic shunt revision.The codman certas valve was explanted and replaced due to a kink in th tubing from the distal takeoff from the valve.There was no harm to the patient.The shunt valve was returned to codman for evaluation.

• Brand Name: CODMAN CERTAS SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÀRL/ DEPUY INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6894012
• MDR Text Key: 87374657
• Report Number: 6894012
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017,09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 82-8804PL
• Device Catalogue Number: 828804PL
• Device Lot Number: 130601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Device Age: 6 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1