inforMED
MalfunctionOVN

SUTURE

Received Nov 2, 2017 · Event occurred Jun 27, 2017

Report 6995880 · MDR key 6995880

Device

Generic name

Suture Kit

Manufacturer

Covidien

Product problems

  • Insufficient Device Problem Information

Patient

43 YR

  • Discharge
  • Discharge

Narrative

Description of Event or Problem

PT. ARRIVED TO THE (B)(6) CENTER FOR RETRIEVAL OF A FOREIGN BODY FROM HER LEFT BREAST RETROAREOLAR AREA. SEQUENCE OF EVENTS: ULTRASOUND LEFT BREAST INDICATION: LEFT NIPPLE DISCHARGE. -RECOMMENDED LEFT DUCTOGRAM. SURGICAL CONSULT. TWELVE DAYS LATER: DUCTOGRAM- UNABLE TO PERFORM LEFT DUCTOGRAM, NO NIPPLE DISCHARGE. SURGICAL FOLLOW-UP WITH THE PATIENT'S BREAST SURGEON. TWO DAYS LATER: LEFT BREAST MRI PERFORMED. IMPRESSION; NONSPECIFIC TINY FOCUS OF ENHANCEMENT WITHIN THE NIPPLE. THERE IS NO ADDITIONAL ABNORMALITY SEEN IN THE LEFT BREAST TO ACCOUNT FOR THE PATIENT'S LEFT NIPPLE INVERSION. RECOMMENDED SURGICAL CONSULTATION. EIGHT DAYS LATER: LEFT NIPPLE EXPLORATION AND CENTRAL DUCT EXCISION PERFORMED IN THE OPERATING ROOM. ABOUT 11 MONTHS LATER: LEFT BREAST DIGITAL MAMMOGRAM- A NEW 1.3X0.5 MM RADIOPAQUE FOREIGN BODY WAS FOUND WITHIN THE LEFT RETROAREOLAR BREAST WHICH WAS NOT PRESENT ON PRIOR STUDY. THE FINDINGS WERE DISCUSSED WITH THE PATIENT'S SURGEON. ABOUT 1 MONTH LATER: STEREOTACTIC WITH SPECIMEN OF THE LEFT BREAST WAS ORDERED. SUCCESSFUL STEREOTACTICALLY GUIDED RETRIEVAL OF A RADIOPAQUE FOREIGN BODY WITHIN THE RETROAREOLAR LEFT BREAST.