MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION CODMAN CERTAS SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 828804PL

Device Problems Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

On imaging shunt was found to be in suboptimal position and there was fluid tracking around catheter.During shunt revision, csf flow was under moderately high pressure.The manometer was then brought into the field and connected to the proximal portion of the valve.However, there was no distal runoff through the valve.In fact, we could not forcefully irrigate through the valve either.The valve was then removed and we investigated distal runoff directly to the peritoneal catheter, which was found to be flowing appropriately without resistance.Decision was therefore made to exchange the valve.

• Brand Name: CODMAN CERTAS SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 10395340
• MDR Text Key: 202524403
• Report Number: 10395340
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/07/2020,07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 828804PL
• Device Catalogue Number: 82-8804PL
• Device Lot Number: 4235934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other