RAIN Sheath Transradial 506610NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032082167), received between Jul 6, 2021 and Jul 6, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2021Fracture; Fracture

  AS REPORTED, THAT DURING A LEFT HEART CATHETERIZATION (LHC) PROCEDURE, THE DOCTOR ATTEMPTED TO GAIN ACCESS INTO THE RADIAL ARTERY AND WHEN HE TRIED TO INSERT THE WIRE OF 6F 10CM TRANSRADIAL RAIN SHEATH INTRODUCER IT WOULD ONLY GO SO FAR AND THEN NOT ADVANCE ANYMORE. THEY TRIED GAINING ACCESS FOR APPROXIMATE 20 MINUTES. WHEN THEY TRIED TO REMOVE THE WIRE THROUGH THE NEEDLE, IT WAS REPORTED THAT THE WIRE WAS STUCK AND WOULD NOT COME OUT. ANOTHER DOCTOR WAS EVENTUALLY CALLED IN TO THE ROOM TO TRY TO ASSIST. AT SOME POINT THE WIRE WAS REMOVED, BUT THE TIP OF THE WIRE HAD BROKEN OFF AND THE NEW DISTAL END HAD SHEARED. A VASCULAR SURGEON WAS CALLED IN TO TRY AND RETRIEVE THE DISTAL TIP BUT WAS NOT SUCCESSFUL. THEY PERFORMED A CUT DOWN OF THE ARTERY AND AS REPORTED BY THE TECH, THE DISTAL TIP WAS NOT VISIBLE IN THE ARTERY BUT WAS RETRIEVED FROM THE MUSCLE. ANOTHER NURSE IN THE ROOM HAD THE SAME ACCOUNT OF THE PROCEDURE, HOWEVER, THE VASCULAR SURGEON DID NOT DICTATE THAT IN HIS NOTES. THE PATIENT WAS OK AND WENT HOME THE SAME DAY. THEREFORE, THE LEFT HEART CATHETERIZATION (LHC) PROCEDURE WAS COMPLETED BY GOING IN THROUGH THE FEMORAL ARTERY ACCESS. THE OPERATOR WAS TRAINED TO THE TRANSRADIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121771 ↗