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

Description of Event or Problem

IT WAS REPORTED THAT THE FIRST CATH-GARD CONTAMINATION SLEEVE WAS INITIALLY SECURED BY THE PHYSICIAN; HOWEVER, DUE TO SIGNIFICANT LEAKAGE OBSERVED APPROXIMATELY 1-2 HOURS AFTER PLACEMENT, THE PHYSICIAN ATTEMPTED TO FURTHER TIGHTEN THE DEVICE. THIS ADDITIONAL MANIPULATION MAY HAVE RESULTED IN DAMAGE TO THE LOCKING MECHANISM PROXIMAL TO THE PATIENT. A SECOND CATH-GARD CONTAMINATION SLEEVE WAS SUBSEQUENTLY PLACED AND SECURED FOLLOWING THE SALES REPRESENTATIVE'S RECOMMENDATIONS. THE DEVICE FUNCTIONED AS INTENDED FOR APPROXIMATELY 24-48 HOURS. THEREAFTER, THE HEALTHCARE PROFESSIONAL OBSERVED BACKFLOW OF BLOOD INTO THE TEMPORARY TRANSVENOUS PACING (TVP) SLEEVE LOCATED IN THE RIGHT INTERNAL JUGULAR VEIN. UPON ASSESSMENT, A LARGE AMOUNT OF BLOOD WAS NOTED WITHIN THE SLEEVE. THE PACING CATHETER AND CATH-GARD SLEEVE WERE REMOVED; HOWEVER, CONTINUED OOZING OF BLOOD FROM THE SHEATH HUB WAS OBSERVED. A MOSQUITO CLAMP WAS APPLIED TO GENTLY COMPRESS THE VALVE DUE TO SUSPECTED HEMOSTATIC VALVE MALFUNCTION. THIS INTERVENTION SUCCESSFULLY CONTROLLED THE BLEEDING. A SECOND PACING CATHETER KIT WAS THEN OPENED, AND A NEW PACING CATHETER AND SHEATH WERE INSERTED. THE LOCKING MECHANISM WAS SECURED IN ACCORDANCE WITH THE RECOMMENDED PROCEDURE. ON OVERNIGHT FOLLOW-UP, MINIMAL FLUID (< 1 ML) WAS OBSERVED WITHIN THE SLEEVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EVENT. ASIDE FROM A PROLONGED INSERTION TIME, NO ADVERSE CLINICAL EFFECTS WERE REPORTED. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED A PERMANENT PACEMAKER. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THAT DESCRIBED. ASSOCIATED MDRS INCLUDE 3010532612-2026-00684.

Additional Manufacturer Narrative

(B)(4).