MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION HERMETIC VENTRICULAR CATHETER SET; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number INS-4500

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/17/2019

Event Type  malfunction  

Event Description

With the removal of the ventriculostomy, the catheter broke and the distal 3cm of catheter was retained subcutaneously.

• Brand Name: HERMETIC VENTRICULAR CATHETER SET
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 9847507
• MDR Text Key: 183898550
• Report Number: 9847507
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS-4500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1