ATEC INTRODUCER LOCALIZATION SET SURESIGHT
Received Jul 1, 2015 · Event occurred Jun 8, 2015
Report 1222780-2015-00121 · MDR key 4902330
Device
Product problems
- Detachment Of Device Component
- Component Falling
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PHYSICIAN PERFORMED AN ATEC BREAST BIOPSY PROCEDURE ON (B)(6) 2015. "WHEN THE PHYSICIAN REMOVED THE SECOND OBTURATOR THE CLEAR PIECE OF IT CAME OFF AND REMAINED IN THE PATIENT'S BREAST". THE CLEAR PIECE REMAINED INSIDE THE PATIENT AS THE PATIENT WAS GOING TO HAVE SURGERY SOON AFTER THE BIOPSY PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITH NO ADVERSE CONSEQUENCES.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).