FDA.report

MAUDE MDR 4710281

MDR report key
4710281
Report number
3005172759-2015-00007
Event key
0
Event type
3
Date of event
2015-03-30
Date received
2015-04-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Related Records

Manufacturer Contact

Contact
IZABEL NIELSON, SR. MGR.
Address
1525-B O'BRIEN DR. MENLO PARK CA 94025 US
Phone
650-650-6506
Report source
M
Manufacturer link flag
Y

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RELIEVA VORTEX 2 SINUS IRRIGATION CATHETERIRRIGATION CATHETERACCLARENTKARNARV02UNKR N

Patients

SequenceReceivedTreatmentOutcome
12015-04-1701. R

Event Narratives

D

Patient 1

ACCLARENT WAS INFORMED OF AN EVENT THAT OCCURRED DURING A PROCEDURE IN WHICH A RELIEV A VORTEX 2 SINUS IRRIGATION CATHETER WAS USED. DURING THE PRIMARY MAXILLARY ANTROSTOMY PROCEDURE, THERE WAS NO DIFFICULTY REPORTED IN ACCESSING OR DILATING THE MAXILLARY SINUS. FOLLOWING DILATION OF THE SINUS OSTIUM, THE SURGEON WAS SAID TO HAVE USED 5CCS OF SALINE AT LOW PRESSURE TO OBTAIN A CULTURE FROM THE MAXILLARY SINUS, WITH NO REPORTED SWELLING. A HIGHER PRESSURE LAVAGE WAS THEN PERFORMED TO WASH OUT THE MAXILLARY SINUS. SOMETIME THEREAFTER, THE PATIENT WAS NOTED TO HAVE POST SEPTAL ORBITAL SWELLING AROUND THE LEFT EYE. THE SURGEON PERFORMED A LATERAL CANTHOTOMY TO RELIEVE THE SWELLING. THE PATIENT WAS SENT BY AN OPHTHALMOLOGIST IN THE RECOVERY ROOM, AND THERE WERE NO VISION CHANGES REPORTED. PATIENT FOLLOW UP OCCURRED THE FOLLOWING WEEK AND SHOWED THE PATIENT WAS DOING WELL WITH NO FURTHER SEQUELAE REPORTED.

N

Patient 1

THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS DISCARDED BY THE USER FACILITY AND WAS NOT AVAILABLE FOR EVALUATION. MANUFACTURING RECORDS ASSOCIATED WITH THE SUBJECT DEVICE COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. THE PHYSICIAN REPORTED HAVING NO DIFFICULTIES IN USING THE ACCLARENT DEVICES DURING THE PROCEDURE. THE SURGEON REPORTED THAT THE SWELLING WAS RELATED TO THE IRRIGATION, NOT THE BALLOON. THE SURGEON ALSO COMMENTED THAT THE SWELLING RESULTED FROM A PRE-EXISTING DEFECT IN THE PATIENT'S ORBIT THROUGH WHICH THE SALINE IRRIGATION FLUID ENTERED THE ORBITAL SPACE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED, AND ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

Related GUDID Devices By Product Code

Primary DIBrandCompanyProduct codePublished
06978785665117InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665124InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665148InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665056InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-08-08
00194613022020MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022044MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022051MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022068MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022075MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022082MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00805106849603XTREMEXtreme Personal Care Inc.KAR2025-04-20
00194613022006MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022013MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022037MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022099MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00887482123874Symmetry Surgical®SYMMETRY SURGICAL INC.KAR2024-08-15
00887482124970Symmetry Surgical®SYMMETRY SURGICAL INC.KAR2024-08-15
00888515244573BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515244597BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251014BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251038BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251045BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251052BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251076BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251120BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251137BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251144BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251151BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251175BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
G586E97332590Novo SurgicalNOVO SURGICAL, INC.KAR2023-12-18

Related PMN/PMA Records By Product Code

TypeSubmissionProduct codeDeviceApplicantDecision date
510(k)K131177KARSINUFLUSH LAVAGE SYSTEMHedgepath, LLC2013-09-20
510(k)K931398KARGM SWIVEL VIDEO (TM) IRRIGATORGm Engineering, Inc.1993-08-30
510(k)K861298KARFISCH DRILL IRRIGATORJedmed Instrument Co.1986-04-23