MAUDE MDR 9875888

MDR report key
9875888
Report number
3006524618-2020-00124
Event key
0
Event type
3
Date received
2020-03-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
HOLLY TOPPING
Address
7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US
Phone
512-512-5123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
19CM ANTERIOR/POSTERIOR DUALBALLOON, EPISTAXISARTHROCARE CORP.EMXRR 900UNKNOWN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2401. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PATIENT HAD HIGH-VELOCITY IMPACT TO HIS FACE BY A FENCE POST THAT CAUSED EXTENSIVE FACIAL INJURIES, AND A GLASGOW COMA SCALE FLUCTUATING BETWEEN 3 AND 6. HE WAS INTUBATED AT THE SCENE AND DURING TRANSIT HE DEVELOPED BRISK EPISTAXIS THEREFORE A 9 CM RAPID RHINO WAS USED HOWEVER REPEAT COMPUTED TOMOGRAPHY SCAN DEMONSTRATED THIS BALLOON HAD AGAIN MIGRATED INTRACRANIALLY. THE BALLOON WAS AGAIN DEFLATED, MANUALLY REMOVED AND REPLACED WITH A SHORTER 5.5-CM RAPID RHINO, WITH CORRECT POSITIONING CONFIRMED RADIOGRAPHICALLY. THE PATIENT HAD A PROLONGED STAY IN THE INTENSIVE CARE UNIT AND WAS TREATED PROPHYLACTICALLY WITH ANTIBIOTICS TO PREVENT INTRACRANIAL INFECTION. THE RAPID RHINO WAS REMOVED AFTER 72 HOURS AND NO FURTHER EPISTAXIS OCCURRED. SERIAL IMAGING DEMONSTRATED DEVELOPMENT OF A TRAUMATIC ENCEPHALOCELE WHICH WAS SURGICALLY REPAIRED VIA BIFRONTAL CRANIOTOMY. HE MADE AN UNEVENTFUL RECOVERY FOLLOWING THIS PROCEDURE AND WAS DISCHARGED HOME AFTER INTENSIVE NEUROREHABILITATION IN THE HOSPITAL BRAIN INJURIES REHABILITATION UNIT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.