FDA.reportPublic FDA data

MAUDE MDR 7759962

MDR report key
7759962
Report number
2951238-2018-00452
Event key
0
Event type
3
Date of event
2018-07-12
Date received
2018-08-07
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
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 46 CM 5/BXUROPASS ACCESS SHEATHTELEFLEX MEDICAL OEMKNY61346BX61346BX09B1800257Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-0701. O

Event Narratives#

N

Patient 1

THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. TO PREVENT INJURY TO THE PATIENT, THE INSTRUCTION MANUAL WARNS NOT TO ADVANCE THE DEVICE IF RESISTANCE IS FELT OR THE DILATOR IS MISSING. THE PLACEMENT OF THE DILATOR/SHEATH ASSEMBLY MUST ALSO BE CONFIRMED VIA FLUOROSCOPY. THE INSTRUCTION MANUAL ALSO SPECIFIES COMPATIBLE GUIDEWIRE DIMENSIONS, AND ALSO CONTAINS PRE-PROCEDURE INSTRUCTIONS TO INSPECT THE DEVICE FOR DAMAGE BEFORE USE.

D

Patient 1

OLYMPUS WAS INFORMED THAT AT THE BEGINNING OF A URETEROSCOPY PROCEDURE, THE INNER DILATOR TIP OF THE DEVICE FELL OFF INTO THE PATIENT WHILE THE DEVICE WAS BEING ADVANCED INTO THE URETER OVER A GUIDEWIRE. IT WAS REPORTED THAT DURING ADVANCEMENT OF THE DEVICE, RESISTANCE WAS FELT, AND X-RAY CONFIRMED THAT THE FALLEN OFF TIP WAS NO LONGER IN THE URETER. THE FALLEN OFF DEVICE TIP WAS FLUSHED OUT OF THE BLADDER WITH AN ELLIK DEVICE. IT WAS REPORTED THAT THE PATIENT SUSTAINED A MILD DEGREE OF TISSUE TRAUMA DUE TO THE EVENT. THE STENT ASSOCIATED WITH THE INITIAL PROCEDURE WAS LEFT IN PLACE TO ADDRESS THE TISSUE TRAUMA. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY DOING WELL.