FDA.reportPublic FDA data

MAUDE MDR 7276189

MDR report key
7276189
Report number
MW5075316
Event key
0
Event type
3
Date of event
2018-02-13
Date received
2018-02-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAREFUSIONTEMNO BIOPSY NEEDLECAREFUSIONIKT22G X 15CMACT22150000965342I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-150

Event Narratives#

D

Patient 1

DURING CUT GUIDED LUNG BIOPSY, MD PLACED THE INTRODUCER IN THE PT FOR A LUNG BIOPSY. THE NEEDLE WOULD NOT GO THROUGH THE INTRODUCER. PHYSICIAN SAID IT FELT LIKE THERE WAS OBSTRUCTION. NEEDLE AND INTRODUCER REMOVED. NEW DEVICE OPENED AND THE PROCEDURE WAS COMPLETED. POST PROCEDURE THE PT DEVELOPED A PNEUMOTHORAX. THE MD STATES IT MAY OR MAY NOT BE RELATED TO THE DEFECTIVE DEVICE AS THE PT WAS ALSO COUGHING DURING THE PROCEDURE.