FDA.reportPublic FDA data

MAUDE MDR 1362661

MDR report key
1362661
Report number
1362661
Event key
0
Event type
3
Date of event
2009-03-05
Date received
2009-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RELIEVA SOLO BALLOON CATHETERBALLOON CATHETER, SINUSACCLARENT, INC.KAOGCO20RS** R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-03-250

Event Narratives#

D

Patient 1

THE SINUS GUIDE CATHETER WAS INTRODUCED INTO THE SINUS UNDER ENDOSCOPIC VISUALIZATION. A FLEXIBLE SINUS GUIDEWIRE WAS INTRODUCED THROUGH THE SINUS GUIDE CATHETER AND ADVANCED WITHIN THE TARGET SINUS UNDER FLUOROSCOPIC GUIDANCE. THE POSITION OF THE SINUS BALLOON CATHETER WAS CONFIRMED, AND WAS GRADUALLY DILATED, WHEN THE BALLOON BROKE OFF THE END OF THE GUIDE WHILE IN THE SINUS. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE BALLOON AND GUIDE WITHOUT ANY PROBLEMS. THE GUIDE AND BALLOON WERE GIVEN TO THE SURGICAL SERVICE TEAM LEADER TO RETURN TO THE COMPANY FOR AN EVALUATION. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT RELATED TO THE RUPTURE OF THE BALLOON.

D

Patient 1

THE SINUS GUIDE CATHETER WAS INTRODUCED INTO THE SINUS UNDER ENDOSCOPIC VISUALIZATION. A FLEXIBLE SINUS GUIDEWIRE WAS INTRODUCED THROUGH THE SINUS GUIDE CATHETER AND ADVANCED WITHIN THE TARGET SINUS UNDER FLUOROSCOPIC GUIDANCE. THE POSITION OF THE SINUS BALLOON CATHETER WAS CONFIRMED, AND WAS GRADUALLY DILATED, WHEN THE BALLOON BROKE OFF THE END OF THE GUIDE WHILE IN THE SINUS. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE BALLOON AND GUIDE WITHOUT ANY PROBLEMS. THE GUIDE AND BALLOON WERE GIVEN TO THE SURGICAL SERVICE TEAM LEADER TO RETURN TO THE COMPANY FOR AN EVALUATION. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT RELATED TO THE RUPTURE OF THE BALLOON.