MAUDE Adverse Event Report: PRO-GAV MEIETHKE CATHETER; VENTRICULAR PERITONEAL CATHETER

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 08/17/2016

Event Type  Injury  

Event Description

Removed due to suspected malfunction per surgeon.Sent to risk management and back to manufacture for device evaluation for further testing of device per surgeon request.

• Brand Name: PRO-GAV MEIETHKE CATHETER
• Type of Device: VENTRICULAR PERITONEAL CATHETER
• MDR Report Key: 5895877
• MDR Text Key: 52863686
• Report Number: MW5064251
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR