FDA.reportPublic FDA data

MAUDE MDR 8234412

MDR report key
8234412
Report number
2951238-2019-00349
Event key
0
Event type
3
Date of event
2018-12-14
Date received
2019-01-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CONNIE TUBERA
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STANDARD BALL00N CATHETER,SILICONE (6/PK)BALLOON, EPISTAXISGYRUS ACMI, INCEMX890923MH807753R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-1001. H; 2. R

Event Narratives#

N

Patient 1

THE DEVICE HAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. DESPITE SEVERAL FOLLOWUP ATTEMPTS, THERE IS NO FURTHER INFORMATION REGARDING THE SEQUENCE OF EVENTS LEADING TO THE BURSTING, WHETHER THE DEVICE WAS INSPECTED BEFORE USE, PATIENT PRE-EXISTING CONDITIONS, OR THE CURRENT PATIENT STATUS. AS A PREVENTIVE MEASURE AGAINST DEVICE MALFUNCTION, THE DEVICE INSTRUCTION FOR USE DOCUMENT CAUTIONS ?INSPECT ALL PACKAGES FOR PUNCTURES OR EVIDENCE OF CONTAMINATION PRIOR TO OPENING.? AS A GENERAL PRECAUTION AGAINST PATIENT INJURY, THE INSTRUCTION FOR USE DOCUMENT ALSO STATES THAT THE PATIENT TISSUE SHOULD BE REGULARLY INSPECTED WHILE THE INFLATED DEVICE IS IN USE DUE TO POTENTIAL PRESSURE NECROSIS.

D

Patient 1

1 OF 3. OLYMPUS WAS INFORMED THAT DURING A DURING A SINUS SEPTOPLASTY PROCEDURE, THE BALLOON PORTION OF THE DEVICE BURST WHILE IN THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL TO COMPLETE THE PROCEDURE. THERE IS CURRENTLY NO FURTHER INFORMATION ON THE PATIENT CONDITION.