EXELON TBA
Received Jul 27, 2006 · Event occurred Jul 10, 2006
Report 6000048-2006-00391 · MDR key 746041
Device
Generic name
Transbronchial Aspiration Needle
Manufacturer
Boston ScientificModel number
*Catalog number
6410
Lot number
8603892
Product problems
- Break
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE COMPLAINANT HAS REPORTED THAT A PT (AGE AND GENDER UNK) UNDERWENT A DIAGNOSTIC TRANSBRONCHIAL NEEDLE ASPIRATION FOR BIOPSY IN 2006. THEY SUCCESSFULLY ADVANCED THE CATHETER TO THE CHANNEL OF THE SCOPE BUT WERE NOT ABLE TO TAKE THE BIOPSY BECAUSE "THE FRONT PART OF THE NEEDLE WAS BROKEN". THERE WAS NO REPORTED COMPLICATION OR ILL EFFECT SUSTAINED BY THE PT.
Additional Manufacturer Narrative
THIS DEVICE HAS NOT BEEN RECEIVED BY THIS MFR. AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECIFICATIONS. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. WE ARE UNALBLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT AT THIS TIME. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT. ACCESS AND MAINTENANCE PROCEDURES.