MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-06 for NUVENT? 1830617SPH manufactured by Medtronic Xomed Inc..
[119344417]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[119344418]
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.
Patient Sequence No: 1, Text Type: D, B5
[131712993]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2018-00413 |
| MDR Report Key | 7850293 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-06 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-09-06 |
| 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 |
| 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 | 3 |
| Brand Name | NUVENT? |
| Generic Name | INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2018-09-06 |
| Returned To Mfg | 2018-10-01 |
| Model Number | 1830617SPH |
| Catalog Number | 1830617SPH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-09-06 |