MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-13 for RAPIDRHINO UNKNOWN manufactured by Arthrocare Corp..
[187907817]
Foreign zip code: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187907818]
It was reported that the patient went to emergency department with a one-day history of right anterior nasal epistaxis, then a rapidrhino 7. 5 cm was inserted and inflated into her right nostril. The pilot cuff and swallow-guard butterfly were taped to the side of the patient's cheek. Twelve hours later, the rapidrhino was deflated to inspect for further bleeding but was re-inflated again as the epistaxis recurred. Around 40 ml of air was inflated to produce a firm pressure from the rapidrhino's pilot cuff. Despite the re-insertion of the rapidrhino, the epistaxis bleeding persisted and became heavier. The patient began to develop severe respiratory distress and developed signs of upper airway obstruction. She became hypoxic at 78% saturation. A throat inspection revealed a dark red circular mass occluding the oropharynx, obstructing ventilation. Initially mistaken as a blood clot, attempts to remove it with surgical forceps proved to be futile. With closer inspection, it was determined that the mass was in fact a blood-soaked herniated rapidrhino balloon, simulating the appearance of a blood clot. Deflation and removal of the rapidrhino resulted in resolution of the airway obstruction. Patient outcome is unknown. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2020-00058 |
| MDR Report Key | 9708006 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDRHINO |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2020-02-13 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |