ARROW PACING/PSI KIT: 5 FR/6 FR 2-L

Description of Event or Problem

IT WAS REPORTED THAT, WITHIN THE CARDIAC CARE UNIT (CCU), STAFF OBSERVED FLUID LEAKAGE AROUND THE CONNECTION AREA OF THE CATH-GARD CONTAMINATION SHEATH IN SEVERAL PATIENTS WITH TEMPORARY TRANSVENOUS PACEMAKERS (TVPS) OVER THE PAST FEW MONTHS. THE OBSERVED LEAKAGE NECESSITATED FREQUENT DRESSING CHANGES. THE TVPS REMAINED IN SITU, AND NO DEVICE REMOVAL OR REPLACEMENT WAS REPORTED IN ASSOCIATION WITH THESE OBSERVATIONS. NO PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

Additional Manufacturer Narrative

(B)(4).