MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-07-18 for PROPEL (MOMETOSONE FUROATE IMPLANT, 370 UG) 70011 manufactured by Intersect Ent.
[4884198]
On (b)(6) 2014, a male pt had functional endoscopic sinus surgery (fess) and was treated with propel sinus stents bilaterally in the ethmoid sinuses. The physician performed an anterior ethmoidectomy, used balloon therapy in the maxillary and frontal sinuses and had uncapped the bulla. The physician used evicel fibrin sealant for hemostasis. On (b)(6) 2014, 4 days post surgery, the implant migrated from the left sinus to the throat. The physician initially reported that the pt was choking and that the airway was obstructed, and later clarified that the pt described feeling something in his throat, felt a chocking sensation and coughed up the implant. It was confirmed the pt did not receive assistance from a third party at the time of the event. The pt brought the implant to the physician the following day and it was discarded. There were no issues reported with right implant. The pt was reported to have to subsequent tissues post event and no additional medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
[12059629]
Based on the company's complaint investigation, the device met its specifications. In an abundance of caution, intersect ent is reporting this event is a malfunction based on the info it received the remote possibility of serious injury should a similar event occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010101669-2014-00002 |
| MDR Report Key | 3979430 |
| Report Source | 05,07 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-03-02 |
| Date Mfgr Received | 2014-06-18 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-08-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | AMY WOLBECK |
| Manufacturer Street | 1555 ADAMS DR |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506412115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPEL (MOMETOSONE FUROATE IMPLANT, 370 UG) |
| Generic Name | DRUG-ELUTING SINUS STENT |
| Product Code | OWO |
| Date Received | 2014-07-18 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 31018001 |
| Device Expiration Date | 2014-10-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-18 |