MAUDE Adverse Event Report: COOK INCORPORATED VENTRICLEAR; CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

Model Number G44130

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/31/2017

Event Type  malfunction  

Event Description

An external ventricular drain (evd) was placed in a patient on [date redacted].During removal of the evd one week later, a 0.5cm portion of the distal tip fractured and was retained.The patient was taken to surgery four days later, and this fragment was retrieved successfully.Manufacturer response for ventricular (per site reporter).Unknown.Pictures were sent to the manufacturer.

• Brand Name: VENTRICLEAR
• Type of Device: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7066562
• MDR Text Key: 93221353
• Report Number: 7066562
• Device Sequence Number: 1
• Product Code: NHC
• 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: Patient
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: G44130
• Device Catalogue Number: 50318
• 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: 11/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR