MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION POLYPROPYLENE CONNECTOR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 999410

Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261); Device Dislodged or Dislocated (2923)

Patient Problem Embolism (1829)

Event Date 01/14/2018

Event Type  malfunction  

Event Description

Patient had piece of shunt break off and travel to his pulmonary artery.Patient brought to operating room for successful retrieval of piece.Physician felt is was an issue with the connector.

• Brand Name: POLYPROPYLENE CONNECTOR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 7266232
• MDR Text Key: 99949631
• Report Number: 7266232
• 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: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 999410
• Device Catalogue Number: 999410
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2018
• Event Location: Home
• Date Report to Manufacturer: 01/29/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARES CATHETER