FDA.reportPublic FDA data

MAUDE MDR 1041247

MDR report key
1041247
Report number
3005249627-2008-00003
Event key
0
Event type
3
Date of event
2007-07-21
Date received
2008-05-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US
Phone
218-218-2183
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THE SPANNER TEMPORARY PROSTATIC STENTTEMPORARY PROSTATIC STENTABBEYMOOR MEDICAL INC.NZCCE SPNR-9C97NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-05-0901. R

Event Narratives#

D

Patient 1

WHILE SOLICITING PRODUCT PERFORMANCE FEEDBACK FROM CLINICIANS, THE DEVICE MANUFACTURER LEARNED OF A DEVICE MIGRATION EVENT. THE PT VOIDED FINE AFTER SPANNER INSERTION IN 2007. ON THREE DAYS LATER, HE WAS UNABLE TO VOID (ACUTE URINARY RETENTION). THE REMOVAL TETHER WAS NOT VISIBLE AND A FOLEY CATHETER WAS INSERTED, WHICH PUSHED THE SPANNER INTO THE BLADDER. THE DEVICE WAS REMOVED VIA CYSTOSCOPY. ACCORDING TO THE CLINICIAN, ACUTE URINARY RETENTION MAY HAVE BEEN CAUSED DUE TO OBSTRUCTED DEBRIS, TRUE CAUSE IS UNKNOWN. INDICATION FOR USE: PT WAS ON WAITING LIST FOR OPEN PROSTATECTOMY SURGERY. THE SPANNER HAD BEEN IN USE FOR THREE DAYS.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVAL. A REVIEW OF DEVICE HISTORY RECORDS (DHR) FOR THIS SPANNER LOT REVEALED NO INDICATION THAT THE DEVICE USED DID NOT MEET SPECIFICATIONS. DEVICE NOT RETURNED - NO EVAL WILL BE PERFORMED. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES.