VSI IPN028418Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156102685), received between Jul 14, 2020 and Dec 15, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  MEDSUN REPORT UF/IMPORTER REPORT# 1300060000-2020-8021 RECIEVED ON 07JAN2021. DESCRIBE THE EVENT OR PROBLEM: OBTAINING FEMORAL VENOUS ACCESS IN THE EP LAB PER PROTOCOL WITH VSI MICRO-INTRODUCER KIT (REF# (B)(4); LOTI675840). WHILE TECHNICIAN WAS EXCHANGING MICRO WIRE FOR LARGER WIRE THE MICRO SHEATH BROKE AT THE HUB, LEAVING ABOUT 7CM OF THE MICRO SHEATH IN THE PT'S VEIN AND/OR SUBCUTANEOUS TISSUE. AN ATTEMPT WAS MADE BY PROVIDER TO GRAB THE SHEATH WITH HEMOSTATS BUT HE WAS UNABLE TO RETRIEVE IT. DR. ARRIVES TO ATTEMPT TO REMOVE THE SHEATH AFTER CUTTING DOWN THE SKIN. HE WAS UNSUCCESSFUL IN DOING SO. HE IS NOW GOING TO MOVE THE PATIENT TO THE OR TO PERFORM A DEEPER CUT DOWN TO REMOVE THE SHEATH. PRIOR TO ABLATION BEING PERFORMED A SMALL SHEATH BROKE, SUCH THAT THE MAJOR LENGTH OF THE SHEATH WAS IN THE RIGHT EXTERNAL ILIAC VEIN. ATTEMPTS TO REMOVE THE SHEATH BY EXPLORING SUBCUTANEOUSLY WERE UNSUCCESSFUL AND FLUOROSCOPY OF THE SHEATH DEMONSTRATED MOVEMENT WITH THE CARDIAC CYCLE SUGGESTING AN INTRAVASCULAR LOCATION. THE PATIENT SUBSEQUENTLY UNDERWENT RIGHT EXTERNAL ILIAC VENOUS DISSECTION AND VENOTOMY WITH RETRIEVAL OF THE SHEATH BY DR. THE PATIENT WAS MONITORED OVERNIGHT AND HAS REMA

  Patient problems: Foreign Body In Patient

  MAUDE report 11010748 ↗
• MalfunctionJul 14, 2020Separation Problem; Separation Problem

  AS REPORTED THE PATIENT WAS IN THE CARDIAC CATH LAB (CCL) FOR A LEFT HEART CATH. PER THE PHYSICIANS' DICTATION, HE INITIALLY TRIED ACCESSING THE R FEMORAL ARTERY USING MICRO-PUNCTURE. THERE WAS DIFFICULTY ADVANCING THE WIRE, SO THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE BUT EXPERIENCED DIFFICULTY RETRACTING. THE ACCESS NEEDLE WAS THEN REMOVED BUT THE WIRE STILL WOULDN'T PULL BACK. THE PHYSICIAN THEN PULLED WITH MORE FORCE AND THE TIP OF THE WIRE WAS DISLODGED WITH SOME THREADING OF THE WIRE AS IT WAS REMOVED AND "A VERY SMALL PORTION OF THE WIRE TIP WAS SEEN ON FLUORO, BUT IT APPEARED EXTRAVASCULAR." NO FURTHER COMPLICATIONS WERE REPORTED. THERE WAS NO DOCUMENTATION PERTAINING TO THE PLANNED REMOVAL OF THE FOREIGN BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10272979 ↗