inforMED
MalfunctionHMW

LACRICATH LACRIMAL DUCT CATHETER, 3.0MM

Received Apr 12, 2006 · Event occurred Feb 17, 2006

Report 1649914-2006-00021 · MDR key 701734

Device

Generic name

Manual Ophthalmic Surgical Instrument: Lacrymal Dilator

Model number

LDC315

Catalog number

*

Lot number

24630.08X

Product problems

  • Balloon leak(s)
  • Replace
  • Balloon pinhole

Patient

UNKNOWN

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

A DR HAD INSERTED THE CATHETER INTO THE PUNCTA AND BEGAN INFLATION. THE BALLOON LEAKED-TT WAS DISCOVERED THERE WAS A HOLE IN THE BALLOON END. THE DOCTOR USED SPARE CATHETER FROM SAME BOX AND LOT, PROCEDURE WENT WITHOUT FURTHER PROBLEMS. NO PATIENT COMPLICATIONS WERE REPORTED. THE PART NUMBER OF THE KIT IS DCP315-UNIT, LOT 25057. THE PART NUMBER OF THE DEVICE THAT ALLEGEDLY FAILED IS LDC315, FROM LOT 24630.08Z. THE MDR WILL BE FILED ON THE LDC315 CODE.