FDA.reportPublic FDA data

MAUDE MDR 9104106

MDR report key
9104106
Report number
2951238-2019-01127
Event key
0
Event type
3
Date of event
2019-08-18
Date received
2019-09-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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
1UROPASS AS 13/15FR X 54 CM 5/BXUROPASS AS 13/15FR X 54 CM 5/BXTELEFLEX MEDICAL OEMKNY61354BX09M170013R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-230

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE 61354BX INSTRUCTION MANUAL ?AVOID CONTACT WITH SHARP OBJECTS AS THE DEVICE CAN BE EASILY NICKED, THEREBY INCREASING THE POTENTIAL FOR BREAKAGE.?

D

Patient 1

THE SERVICE CENTER WAS INFORMED THAT DURING THAT AN UNSPECIFIED PROCEDURE, THE ACCESS SHEATH BROKE DURING INSERTION. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.