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

Model Number 1830617SPH

Device Problems Break (1069); Material Rupture (1546); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider (hcp) reported via a manufacturer representative that the balloon seeker broke during a functional endoscopic sinus surgery procedure.When the sphenoid sinus was ballooned, the balloon popped and would not inflate or deflate while inside the patient.The balloon was replaced with a back-up device which delayed the case by three minutes with no negative patient impact.

Manufacturer Narrative

Analysis confirmed with a syringe that there was a leak in the device.Visually, there was a puncture in the balloon which was 0.10¿ long and had small abrasions leading up to it, it was approximately perpendicular to the main shaft.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 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: 7850293
• MDR Text Key: 119344417
• Report Number: 1045254-2018-00413
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1830617SPH
• Device Catalogue Number: 1830617SPH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 53 YR
• Patient Weight: 71