ACHIEVE NEEDLE BIOP SO TIS 20GX11CM COAX
Received Oct 22, 2014 · Event occurred Jul 10, 2014
Report 9680904-2014-00042 · MDR key 4193979
Device
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4): FAILURE MODE COULD NOT BE CONFIRMED SINCE SAMPLES WERE NOT RECEIVED FOR EVALUATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD FOR THE REPORTED LOT NUMBER WAS PERFORMED AND IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. NO ISSUES WERE FOUND THAT COULD RELATE EQUIPMENT/MACHINE TO THE REPORTED FAILURE MODE. MOST PROBABLE CAUSE COULD NOT BE DETERMINED SINCE NO ISSUES WERE FOUND DURING APPLICABLE MANUFACTURING AND PACKAGING PROCESSES THAT CAN RELATE PERSONNEL OR METHOD WITH THE REPORTED FAILURE AND SINCE SAMPLE WAS NOT RECEIVED FOR MATERIAL EVALUATION.
Description of Event or Problem
REPORTED VIA MEDWATCH MW5037330: TIP OF BIOPSY GUN BROKE OFF INSIDE PATIENT'S LUNG. NO HARM TO PATIENT. NO INTERVENTION REQUIRED.
Additional Manufacturer Narrative
(B)(4): IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 07NOV2014: THE COMPONENT BROKE DURING THE FIRING OF THE GUN FOR TISSUE COLLECTION. THE MASS BEING BIOPSIED WAS AT THE CHEST WALL-POSSIBLY HIT RIB MARGINS. THE TISSUE BEING BIOPSIED COULD POSSIBLY HAVE BEEN HARDER OR MORE RIGID THAN THE CLINICIAN INTENDED. THE TIP OF THE TISSUE COLLECTOR BROKE. THE USER WAS EXPERIENCED. NO INJURY TO THE PATIENT, IT WAS IN THE TISSUE OUTSIDE THE LUNG, NO DAMAGE. THERE ARE NO KNOWN CURRENT PROBLEMS REGARDING THE PATIENT'S STATUS.
Additional Manufacturer Narrative
(B)(4). UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.