MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NUVENT¿; INSTRUMENT, ENT MANUAL SURGICAL

Model Number 1830717FRT

Device Problem Material Integrity Problem (2978)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A health care provider (hcp) reported that during the functional endoscopic sinus surgery (fess), the patient had cerebrospinal fluid (csf) leak from the standard frontal balloon.They were alleging that it was due to the stiffness of the balloon.There was a 45 minute delay.They were able to stop the leak using a cartilage graft and some other device.The patient was observed overnight.There was no further issues or impact.The case was not aborted.

• Brand Name: NUVENT¿
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7973886
• MDR Text Key: 123977567
• Report Number: 1045254-2018-00518
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1830717FRT
• Device Catalogue Number: 1830717FRT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 82