MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-07 for NUVENT? 1830717FRT70 manufactured by Medtronic Xomed Inc..
[126648035]
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.
Patient Sequence No: 1, Text Type: N, H10
[126648036]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2018-00572 |
| MDR Report Key | 8048091 |
| Date Received | 2018-11-07 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-10 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2018-11-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUVENT? |
| Product Code | LRC |
| Date Received | 2018-11-07 |
| Returned To Mfg | 2018-10-15 |
| Model Number | 1830717FRT70 |
| Catalog Number | 1830717FRT70 |
| Lot Number | 0215563219 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-07 |