FDA.reportPublic FDA data

MAUDE MDR 7412400

MDR report key
7412400
Report number
9680904-2018-00008
Event key
0
Event type
3
Date of event
2018-02-23
Date received
2018-04-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BDX ANNA WEHRHEIM
Address
75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACHIEVE NEEDLE BIOPSY TIS 16GX11CMBIOPSY NEEDLES & TRAYSCAREFUSION, INCGDFCA16110001138553Y *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-1001. O

Event Narratives#

N

Patient 1

(B)(4) FOLLOW UP SUBMISSION WILL BE COMPLETED POST INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

D

Patient 1

(FIRING MODE) ?D? WAS PRESSED OUTSIDE OF THE BREAST. WHEN ?A? WAS PRESSED IN THE BREAST THERE WAS STILL A THROW. SPOKE WITH REPORTER VIA TELEPHONE AND SHE STATES "THE NEEDLE EXTENDED BEYOND THE DEPTH IT IS INTENDED." SAMPLE WAS OBTAINED. PATIENT DEVELOPED A SMALL PNEUMOTHORAX . NO ADDITIONAL MEDICAL INTERVENTION REQUIRED, RESOLVED WITHIN ONE WEEK WITHOUT FURTHER COMPLICATION. THREE (3) NEEDLES WERE USED THAT DAY, UNSURE OF WHICH ONE WAS USED IN THIS INSTANCE, ALL THREE WILL BE RETURNED. ADDITIONAL INFORMATION: (B)(6) FEMALE WITH SMALL BODY HABITUS HAD RIGHT BREAST BIOPSY UNDER ULTRASOUND GUIDANCE. COAXIAL AND DEVICE WERE CHECKED FOR COMPATIBILITY PRIOR TO PROCEDURE, THUS USED DURING PROCEDURE. SAME DAY CHEST X-RAY WAS PERFORMED TO CONFIRM PNEUMOTHORAX.