MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION VALVE VENT CATHETER BACTISEAL VENTRICULAR PERITIONEAL SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number NS5448

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 12/10/2018

Event Type  Injury  

Event Description

Ventricular peritoneal revision, hydrocephalus with catheter/shunt fracture; unknown cause.The distal portion of the shunt was torn in an oblique fashion without evident source.

• Brand Name: VALVE VENT CATHETER BACTISEAL VENTRICULAR PERITIONEAL SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; plainsboro NJ 08536
• MDR Report Key: 8175602
• MDR Text Key: 130975351
• Report Number: MW5082223
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NS5448
• Device Catalogue Number: NS5448
• Device Lot Number: HP9629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 2 YR
• Patient Weight: 10