MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICLEAR II; CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIA

Model Number G44130

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Code Available (3191)

Event Date 06/18/2015

Event Type  Injury  

Event Description

Attempted removal of an external ventricular drain (evd), met with resistance, and on third attempt made by different surgeon while applying pressure, evd snapped.Patient taken to or for removal of remaining of drain.No sequalea.Patient discharged home next day.

• Brand Name: VENTRICLEAR II
• Type of Device: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIA
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona dr.; goleta CA 93117
• MDR Report Key: 4891078
• MDR Text Key: 6835195
• Report Number: 4891078
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: G44130
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 21 YR