FDA.reportPublic FDA data

MAUDE MDR 2017349

MDR report key
2017349
Report number
3004962788-2011-00008
Event key
0
Event type
3
Date of event
2011-02-11
Date received
2011-03-09
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#

Contact
LEANN GREENBERG
Address
161 CHESHIRE LANE NORTH SUITE 100 MINNEAPOLIS MN 55441 US
Phone
763-763-7632
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUPERTRAX NEEDLE-TIPPED CYTOLOGY BRUSHCYTOLOGY BRUSHSUPERDIMENSION INC.BTGAKI00140-01SD0910071R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-0901. H

Event Narratives#

D

Patient 1

A SITE REPORTED AFTER A SUPERDIMENSION CASE THAT THE PT HAD A PNEUMOTHORAX. IT WAS FURTHER REPORTED THAT THE PHYSICIAN THOUGHT THE NEEDLE BRUSH USED FOR BIOPSIES MAY HAVE BEEN THE CAUSE BUT HE WAS NOT SURE. THE PT WAS HOSPITALIZED AND WENT HOME THE NEXT DAY. THERE WAS NO ALLEGATION THAT THE SUPERDIMENSION (SD) SYSTEM CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX.

N

Patient 1

PNEUMOTHORAX IS A KNOWN COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY, OR CT-GUIDED PERCUTANEOUS BIOPSY WITH COMPLICATION RATES UP TO APPROXIMATELY 27% WITH THE CT GUIDED PROCEDURE. BIOPSY TOOLS ARE DESIGNED TO HAVE SHARP EDGES AND THEIR FUNCTION IS TO PUNCTURE OR OTHERWISE PENETRATE THE TISSUE IN ORDER TO COLLECT A SPECIMEN.