FDA.reportPublic FDA data

MAUDE MDR 1056491

MDR report key
1056491
Report number
3005249627-2008-00004
Event key
0
Event type
3
Date of event
2008-01-23
Date received
2008-05-30
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 E 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.NZCSPNRSPNR-5CNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-05-3001. R

Event Narratives#

D

Patient 1

DURING ABBEYMOOR MEDICAL REVIEW OF A PHYSICIAN PROVIDED CYSTOSCOPY VIDEO, THE DEVICE MANUFACTURER OBSERVED A COMPLETE DEVICE MIGRATION. THE DEVICE WAS INITIALLY POSITIONED ON 12/19/2007 AND REMOVED BY CYSTOSCOPY IN EARLY 2008. NO KNOWN PATIENT INJURY OR HOSPITALIZATION. NO DEVICE LOT NUMBER PROVIDED. INDICATION FOR USE IS DIFFERENTIAL DIAGNOSIS. NUMBER OF DAYS THE SPANNER HAD BEEN IN USE IS 35 DAYS.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. PHYSICIAN FEEDBACK SUGGESTS THE PATIENT, WHO RESIDED IN A NURSING HOME, WAS DOING OKAY WHILE WEARING THE SPANNER. THE PHYSICIAN SUSPECTS THAT NURSING HOME PERSONNEL MAY HAVE ATTEMPTED INSERTION OF A CATHETER INTO THE PATIENT, THEREBY PUSHING THE SPANNER UP INTO THE BLADDER. THIS FORM FDA 3500A IS BEING SUBMITTED AFTER THE REQUIRED 30-DAY TIME FRAME IN RESPONSE TO RECENT INTERACTIONS BETWEEN ABBEYMOOR, THE FDA LOCAL DISTRICT OFFICE, AND THE FDA REPORTING SYSTEMS MONITORING BRANCH IN WHICH MIGRATION EVENTS WITH CYSTOSCOPIC REMOVAL WERE DEEMED MDR REPORTABLE. (ABBEYMOOR INITIALLY DETERMINED THAT THE MDR WAS NOT REQUIRED FOR THIS EVENT BASED ON RESULTS OF A CLINICIAN-BASED RISK ASSESSMENT).