FDA.reportPublic FDA data

MAUDE MDR 9788153

MDR report key
9788153
Report number
3006345872-2020-00001
Event key
0
Event type
3
Date of event
2020-02-07
Date received
2020-03-04
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. KAREN PETERSON
Address
3600 HOLLY LANE NORTH SUITE 40 PLYMOUTH MN 55447 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LOPROFILE 6X20MMXPRESS ENT DILATION SYSTEMENTELLUS MEDICAL, INC.LRCLPLF-106UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0401. D

Event Narratives#

N

Patient 1

AFTER THE PROCEDURE THE PATIENT'S ROOMMATE INFORMED THE PHYSICIAN THAT THE PATIENT HAD BEEN FEELING SICK, WAS TAKING OTC COLD MEDICATIONS IN THE DAYS PRIOR TO THE PROCEDURE AND FELT LIGHTHEADED AT TIMES. IT WAS DISCOVERED AFTER THE PROCEDURE THAT THE PATIENT HAD A UROLOGY PROCEDURE THE DAY PRIOR TO THE BALLOON PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT FEEL THE EVENT WAS RELATED TO THE DEVICE OR BALLOON DILATION PROCEDURE. THE DEVICE WAS DISCARDED AFTER THE PROCEDURE AND THE LOT NUMBER WAS NOT PROVIDED/KNOWN. THEREFORE, NO INVESTIGATION OF THE DEVICE WAS COMPLETED. DEVICE WAS DISCARDED BY USER.

D

Patient 1

IT WAS REPORTED THAT DURING A BALLOON DILATION OFFICE PROCEDURE, BILATERAL FRONTAL SINUSES WERE TREATED WITHOUT INCIDENT. LEFT SPHENOID DILATION WAS COMPLETED WITH TWO DILATIONS. THE HEALTH CARE PROVIDER TURNED TO THE RIGHT SPHENOID AND ABNORMAL BLEEDING WAS OBSERVED WHEN THE PATIENT COUGHED. THE PATIENT WAS PACKED THEN LOST CONSCIOUSNESS AND VITAL SIGNS DROPPED. THE PATIENT WAS HOSPITALIZED AND ON LIFE SUPPORT. WHILE ON LIFE SUPPORT THE PATIENT WAS DECLARED BRAIN DEAD. PHYSICIAN STATED THE EVENT IS UNRELATED TO THE BALLOON PROCEDURE OR DEVICE.