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

Model Number 1830717FRT70

Device Problems Crack (1135); Material Puncture/Hole (1504); Gas/Air Leak (2946); Material Split, Cut or Torn (4008)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/13/2018

Event Type  Injury  

Manufacturer Narrative

The product analysis confirmed that an opened sample of part number 1830717frt70 from and unknown "loat" was received with biological contaminants on the probe.The reported failure was that the device had a hole in it, and it was suggested that the balloon contributed to a patient injury (cerebrospinal fluid leak within the sinus).Visually, there was no damage to the luer connection or housing, and the probe balloon was filled with a reddish liquid.An inflator and extension line were primed with water and secured to the probe; actuating the inflator showed a leak in the probe balloon which would have resulted in the reported malfunction.There was a jagged puncture 0.33¿ from the distal tip; the puncture measure less than 0.010¿ in diameter; there were multiple abrasions spanning.50¿ leading up to the puncture from the proximal side.There is no allegation of a defect prior to use which likely indicates the damage occurred during use.The information indicates probable causes including: aggressive use, and incorrect balloon size as it relates to the patient¿s anatomy.The ifu / user manual indicates that the device is used in conjunction with a computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures which can be identified relative to a ct- or mr-based model, or digitized landmarks of the anatomy.The balloon dilation is used for pathway expansion effects.Warnings include - do not place metal objects in magnetic field (this could cause navigational inaccuracy); do not use the sinus seeker to perforate thick bone; and use of the incorrect balloon size may cause damage to the sinus balloon and / or surrounding anatomy.Use instructions state that the surgeon should use patient ct scan (hard copies or on medtronic computer-assisted surgery system) to determine the correct balloon size based on the bony margins of the outflow tract and directs the user how to confirm accuracy of the device prior to navigation.If information is provided in the future, a supplemental report will be issued.

Event Description

During a navigated sinus procedure the surgeon ballooned left then right sphenoid with sphenoid balloon.He then switched balloons to a frontal balloon and ballooned left frontal.Went to right frontal to balloon and indicator did not ¿pop¿.Took balloon out, recharged [primed] inflator, went back into frontal, noticed clear liquid and indicator still did not pop.Took balloon out, examined balloon and noticed hole in balloon causing the leak.Another frontal balloon was located and connected to the inflator; and then the inflator was charged [primed].Went back to right frontal, pushed down plunger and indicator did not pop.Noticed air in the line.Pulled balloon back out and recharged [primed] the inflator making sure there was no air in line.Went back into frontal and successfully ballooned.The surgeon then noticed a clear liquid on the right side of the patient's nose that was found to be a csf leak, which was confirmed with a ct scan; "the ct revealed there was a small crack on the posterior side of the frontal sinus".When the csf leak occurred is not known; however, they confirmed that there were no issues with the navigation.The csf leak was treated and at this time the patient is doing fine.

Manufacturer Narrative

Part 18 inf kit nuvent inflator kit lot 0215435205 mfg 2018-05-10 the inflator kit (inflator and extension line) was tested along with the navigated balloon probe.There was no damage to any of the connectors or connected ends.The inflator and extension line were secured while the distal end was blocked off; actuating the inflator by depressing the plunger pressurized the system without any leaks present.There were no faults found with the inflator kit.If information is provided in the future, a supplemental report will be issued.

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 dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint dr. n.; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7766932
• MDR Text Key: 116538600
• Report Number: 1045254-2018-00360
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00643169705289
• UDI-Public: 00643169705289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152121
• 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,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: 1830717FRT70
• Device Catalogue Number: 1830717FRT70
• Device Lot Number: 0215283102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 07/13/2018; 08/08/2018
• Supplement Dates FDA Received: 08/10/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 100