inforMED
MalfunctionGAS

ULTRA FAST-FIX

Received May 21, 2009 · Event occurred Apr 28, 2009

Report 1219602-2009-00163 · MDR key 1458216

Device

Generic name

Ultra Fast-fix Curved Assembly / Gas

Model number

72201491

Catalog number

72201491

Lot number

50252255

Product problems

  • Positioning Failure
  • Device, or device fragments remain in patient

Patient

Not reported

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

T2 DID NOT DEPLOY. THE 1ST T STAYED IN THE PT UNSUPPORTED AND T2 DID NOT DEPLOY. NO OTHER INFO IS AVAILABLE.

Additional Manufacturer Narrative

DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B) (4)