FDA.reportPublic FDA data

MAUDE MDR 2007764

MDR report key
2007764
Report number
2951580-2011-00032
Event key
0
Event type
3
Date of event
2011-01-02
Date received
2011-02-28
Adverse event
1
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RAPID RHINO NASAL CATHETER POSTERIOR EPISTAXISNONEARTHROCARE CORPEMXRR 900UNKR N
144589RAPID RHINO NASAL CATHETER POSTERIOR EPISTAXISNONEARTHROCARE CORPEMXRR 900UNKN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-280L

Event Narratives#

D

Patient 1

A CLINICAL INCIDENT INVOLVING A RAPID RHINO DEVICE WAS REPORTED TO ARTHROCARE CORPORATION. THE PT WAS TREATED WITH A NASAL DRESSING. REPORTEDLY THE DEVICE HAD SLIPPED AND GOT LODGED WITHIN THE PT'S LOWER TRACHEA CAUSING LIMITED BREATHING AND OBSTRUCTING THE AIRWAY SEVERELY, WHICH CAUSED SEVERE DISTRESS TO PT AND NEAR FATAL INJURY. ALTHOUGH THE PT RECOVERED AFTER THE INCIDENT THIS HAS CAUSED NUMEROUS PANIC ATTACKS AND SEVERE PSYCHOLOGICAL DISTRESS TO THE PT. THE PT HAD REPORTED THAT HER AIRWAY WAS OBSTRUCTED BY SOMETHING AT 9 AM ON (B)(6) 2011 AND WAS FINDING IT DIFFICULT TO TALK OR BREATH WHEN SHE HAD BEEN TRANSFER TO THE HOSPITAL. THE PT COMPLAINED THAT SHE COULD NOT BREATH AND THAT THERE WAS SOMETHING SHARP IN HER THROAT, IT WAS VISIBLE TO SEE THAT SHE WAS GETTING LIMITED OXYGEN AS SHE WAS UNABLE TO TALK AND HER EYES WERE BULGING. AN ENT PHYSICIAN TRIED TO SUCTION THE DEVICE FROM THE BACK OF THE PT'S MOUTH TO NO AVAIL, THE PT STARTED TO LOSE CONSCIOUSNESS UPON WHERE A CRASH TEAM WAS CALLED, HOWEVER, A NEARBY ANESTHETIST REALIZED THAT IT WAS THE NASAL PACK WHICH HAD LODGED ITSELF IN THE PT'S THROAT AND DEFLATED THE PACK AND REMOVED IT, FREEING THE PT'S AIRWAY.

N

Patient 1

PT'S INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED IN A FOLLOW UP REPORT. AWAITING FURTHER INFORMATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.