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

Description of Event or Problem

IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE TUOHY-BORST ADAPTER VALVE, RESULTING IN APPROXIMATELY 30ML OF BLOOD LEAKING INTO THE CATH-GUARD AND ONTO THE PATIENT'S NECK AREA. THE USER FACILITY INDICATED THAT SIMILAR LEAKAGE EVENTS HAVE BEEN OBSERVED PREVIOUSLY, WITH VARIABILITY IN SEVERITY. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE REPORTED EVENT. THE PATIENT'S CONDITION WAS DESCRIBED AS "FINE," AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE USER FACILITY FURTHER NOTED THAT, IN MORE SEVERE CASES (NOT CONFIRMED FOR THIS SPECIFIC EVENT), IMMEDIATE PACEMAKER INSERTION HAS BEEN PERFORMED. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE, INCLUDING CONFIRMATION OF THE FREQUENCY OF OCCURRENCE AND ASSESSMENT OF ANY ASSOCIATED PATIENT HARM. THREE ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED. ASSOCIATED MDRS INCLUDE: (SPECIFIC EVENT) AND 3010532612-2026-00650 (MULTIPLE EVENTS WITHOUT ADDITIONAL DETAILS).

Additional Manufacturer Narrative

(B)(4).