MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NUVENT¿

Model Number	1830717FRT70
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Material Separation (1562); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that visually, the press ring was moving freely along the shaft.The press ring is not likely to completely detach from the assembly due to the handle at one end, and the shaft radius and balloon at the other.The balloon assembly should be installed until it stops at the handle, it was 0.147¿ away from the handle which is out of specification.The balloon assembly stopped just distal to the high point on the probe shaft.The probe shaft diameter at this high point shall be 0.1660¿ / +-0.0005¿.The minimal wall thickness of the balloon material shall be 0.0090¿ per side which may be reduced after being assembled onto the shaft diameter.The measurement over the balloon material and high point of the shaft was 0.177¿ which is where the press ring should be seated.The press ring inside diameter shall be 0.180¿ / +-0.001¿; the press ring was forced over the balloon and removed to measure the inside diameter; the ring slid freely along a 0.1813¿ pin which indicates an out of specification condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported via a manufacturer representative that the balloon had a loose metal cuff, the balloon seek er did not inflate and that the metal cuff had broken off and slid forward during a functional endoscopic sinus surgery procedure.A second balloon was opened and the procedure was completed with no issues.There was no delay in the procedure.There was no patient impact.

• Brand Name: NUVENT¿
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8048091
• Report Number: 1045254-2018-00572
• Device Sequence Number: 19197221
• Product Code: LRC
• UDI-Device Identifier: 00643169705289
• UDI-Public: 00643169705289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: 1830717FRT70
• Device Catalogue Number: 1830717FRT70
• Device Lot Number: 0215563219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR