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

Model Number 1830617FRT

Device Problems Material Too Rigid or Stiff (1544); Material Rupture (1546)

Patient Problems Cerebrospinal Fluid Leakage (1772); Sinus Perforation (2277)

Event Date 04/10/2015

Event Type  Injury  

Event Description

It was reported that the balloon ruptured during pre-inflation when it got caught on a bone spur, which caused a micro fracture in the posterior wall of the frontal sinus.On the 2nd attempt, full inflation of the balloon caused a micro csf leak at the micro fracture.The csf leak was repaired with a bone flap which was then covered with a folded flap from the patient's inferior turbinate.The doctor stated that the patient had a large bullae in the posterior sinus, which created a sharp downslope in which the device had to be maneuvered around.Both the rigidity and size of the seeker combined with patient anatomy, contributed to the problem.The patient is since recovering well; no permanent sequela.

Manufacturer Narrative

Blank fields on this report are the result of information not being provided by initial reporter.This device is used for therapeutic purposes.(b)(4).

Manufacturer Narrative

Date of this report: (b)(4) 2015 date received by manufacturer: 06/09/2015.Product evaluation: when compared to the assembly drawing: a syringe was used to inject water into the balloon and there was leakage at the distal tip of the balloon.The fluid leaked underneath and past the metal ring that captures the distal tip of the balloon.The customer stated that difficult maneuvering in the anatomy caused the device to catch on a bone spur and burst while also causing a csf leak.The instructions for use states: ¿ do not use the sinus seeker to perforate thick bone.¿ use of the incorrect balloon size may cause damage to the sinus balloon and / or surrounding anatomy.¿ prior to use, examine the product packaging for damage, deterioration, and expired shelf life.Replace it with an unused system and contact medtronic technical service.Method: actual device evaluated.(b)(4).

Manufacturer Narrative

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

• Brand Name: NUVENT¿
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4748934
• MDR Text Key: 5769925
• Report Number: 1045254-2015-00148
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2016
• Device Model Number: 1830617FRT
• Device Catalogue Number: 1830617FRT
• Device Lot Number: 0209062971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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): Required Intervention
• Patient Age: 00062 YR
• Patient Weight: 68