FDA.reportPublic FDA data

MAUDE MDR 8048091

MDR report key
8048091
Report number
1045254-2018-00572
Event key
0
Event type
3
Date of event
2018-10-01
Date received
2018-11-07
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
URIZA SHUMS
Address
6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
Phone
904-904-9043
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NUVENT?MEDTRONIC XOMED INC.LRC1830717FRT701830717FRT700215563219Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-070

Event Narratives#

N

Patient 1

ANALYSIS FOUND THAT VISUALLY, THE PRESS RING WAS MOVING FREELY ALONG THE SHAFT. THE PRESS RING IS NOT LIKELY TO COMPLETELY DETACH FROM THE ASSEMBLY DUE TO THE HANDLE AT ONE END, AND THE SHAFT RADIUS AND BALLOON AT THE OTHER. THE BALLOON ASSEMBLY SHOULD BE INSTALLED UNTIL IT STOPS AT THE HANDLE, IT WAS 0.147? AWAY FROM THE HANDLE WHICH IS OUT OF SPECIFICATION. THE BALLOON ASSEMBLY STOPPED JUST DISTAL TO THE HIGH POINT ON THE PROBE SHAFT. THE PROBE SHAFT DIAMETER AT THIS HIGH POINT SHALL BE 0.1660? / +-0.0005?. THE MINIMAL WALL THICKNESS OF THE BALLOON MATERIAL SHALL BE 0.0090? PER SIDE WHICH MAY BE REDUCED AFTER BEING ASSEMBLED ONTO THE SHAFT DIAMETER. THE MEASUREMENT OVER THE BALLOON MATERIAL AND HIGH POINT OF THE SHAFT WAS 0.177? WHICH IS WHERE THE PRESS RING SHOULD BE SEATED. THE PRESS RING INSIDE DIAMETER SHALL BE 0.180? / +-0.001?; THE PRESS RING WAS FORCED OVER THE BALLOON AND REMOVED TO MEASURE THE INSIDE DIAMETER; THE RING SLID FREELY ALONG A 0.1813? PIN WHICH INDICATES AN OUT OF SPECIFICATION CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BALLOON HAD A LOOSE METAL CUFF, THE BALLOON SEEK ER DID NOT INFLATE AND THAT THE METAL CUFF HAD BROKEN OFF AND SLID FORWARD DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. A SECOND BALLOON WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.