N/A
Received Mar 25, 2026 · Event occurred Mar 2, 2026
Report 3011640434-2026-00004 · MDR key 24690861
Device
Product problems
- Fluid/Blood Leak
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ON 3-MARCH-2026, IT WAS REPORTED THAT THE PLASTIC TUBING CONNECTED TO THE HUB OF THE SHEATH HAD A HOLE AND WAS LEAKING. ADDITIONAL INFORMATION WAS OBTAINED FROM THE FACILITY AT A LATER DATE AND IT WAS REPORTED THE LEAK WAS IDENTIFIED AT THE BEGINNING OF THE PROCEDURE UPON INSERTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AS A RESULT OF THIS EVENT. THE CASE BEING PERFORMED WAS A VT ABLATION. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR INVESTIGATION ON 6-MAR-2026 FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SHEATH AND DILATOR UPON RECEIPT. THE HEMOSTASIS TUBING WAS NOTED TO HAVE A TEAR NEAR THE HEMOSTASIS HOUSING. THE TUBING WAS ONLY PARTIALLY DETACHED FROM THE HOUSING AND REMAINED ATTACHED TO THE DEVICE. NO OTHER DAMAGE OR DEFECTS WERE NOTED ON THE RETURNED DEVICE. LEAK TESTING OF THE COMPLAINT DEVICE WAS NOT PERFORMED DUE TO THE TORN HEMOSTASIS TUBING. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED TO ENSURE THAT ALL MANUFACTURING AND INSPECTION PROCESS STEPS WERE PERFORMED AND NO ANOMALIES WERE NOTED. BASED ON THE VISUAL INSPECTION RESULTS, THE REPORTED ISSUE IS ABLE TO BE CONFIRMED. AS THE DEVICE MET ALL INSPECTION CRITERIA AT THE TIME OF MANUFACTURING, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem
ON 2-MAR-2026, IT WAS REPORTED THAT THE PLASTIC TUBING CONNECTED TO THE HUB OF THE SHEATH HAD A HOLE AND WAS LEAKING.