MAUDE Adverse Event Report: INNERSPACE INC. HUMMINGBIRD VENTRICULAR; VENTRICULAR CATHETER

Model Number H200MR

Device Problem Fracture (1260)

Patient Problem Hemorrhage, Intraventricular (1892)

Event Date 08/01/2015

Event Type  Injury  

Event Description

During placement of the ventriculostomy catheter the first catheter inserted unfortunately was fractured or lacerated by the inner table and a fragment of catheter was left in situ.

• Brand Name: HUMMINGBIRD VENTRICULAR
• Type of Device: VENTRICULAR CATHETER
• Manufacturer (Section D): INNERSPACE INC. ; 1622 edinger ave.; ste c; tustin CA 92780
• MDR Report Key: 5048851
• MDR Text Key: 24981007
• Report Number: 5048851
• Device Sequence Number: 1
• Product Code: HCA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H200MR
• Device Lot Number: 140616-03
• 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: 08/11/2015
• Distributor Facility Aware Date: 08/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 24 YR
• Patient Weight: 100