inforMED
MalfunctionOFL

TRANSCAROTID/PERIPHERAL ACCESS KIT

Received Jun 30, 2026

Report 1649395-2026-00003 · MDR key 25667496

Device

Generic name

Introducer Kit

Manufacturer

Galt Medical Corp.

Lot number

G25350164

Product problems

  • Material Integrity Problem

Patient

0 DA · Unknown

  • Embolism/Embolus

Narrative

Description of Event or Problem

DR. (B)(6) UTILIZED THE TUNNEL TECHNIQUE AND WENT DIRECTLY INTO THE SKIN WITH THE MPK NEEDLE AND THEN FOLLOWED WITH THE MPK SHEATH WITH THE NON-STIFFENED DILATOR. SHE HAD PUSH ABILITY ISSUES AND COULD NOT SEE THE CM MARKING AT HER ACCESS SITE. IT WAS DECIDED TO SWITCH TO THE STIFFENED DIALATOR AND UPON PULLING OUT THE SHEATH, SHE REALIZED THE MARKING WERE NO LONGER ON THE SHEATH.

Remedial action

  • Recall