RAIN Sheath Transradial 506610HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032079037), received between Jul 15, 2019 and Apr 6, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Unraveled Material; Unraveled Material

  AS REPORTED, THE MINI GUIDEWIRE OF THE 6F 10CM HYDROPHILLIC WIRE (HW) TRANSRADIAL RAIN SHEATH INTRODUCER GOT STUCK IN ITS TUBE. THE SALES REP MENTIONED THAT THE DEVICE WAS DAMAGED AND WAS UNUSABLE. PRODUCT EVALUATION CONFIRMED THAT THE COIL WIRE PRESENTED AN UNRAVELED\STRETCHED CONDITION OBSERVED AT THE 2 CM FROM THE DISTAL CORE WIRE (RIBBON). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED IN THE CATH LAB FOR ONE WEEK. THE DEVICE WILL BE RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619523 ↗
• MalfunctionJul 15, 2019Partial Blockage; Partial Blockage

  AS REPORTED, THE DILATOR IS TOO SOFT AND THE MINI GUIDEWIRE CANNOT ACCESS THE DILATOR ON THE 6F RAIN SHEATH TRANSRADIAL. THE INSERTION DIFFICULTY WAS CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THE .021¿ MINI GUIDEWIRE CAUSED A 5CM HEMATOMA. THE HEMATOMA WAS TREATED WITH COMPRESSION, WITHOUT SEQUELA. THE DOCTOR STATES THE MINI GUIDEWIRE IS TOO FLOPPY. THE DEVICE WAS STORED IN THE CATH LAB IN THE RAIN SHEATH BOX FOR A MAXIMUM OF THREE WEEKS. THE DEVICE WAS INSPECTED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DILATOR WAS HARD TO WIRE AS THERE WAS A VERY SMALL LUMEN IN THE DILATOR. THE DEVICE DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE INSERTION DIFFICULTY. THE PRODUCT NOR ANY OF THE OTHER DEVICES HAD BEEN RESTERILIZED. THE MALFUNCTION WAS NOTED DURING PREP. THE INTENDED PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). THERE WAS NO DIFFICULTY TRACKING THROUGH THE VASCULATURE. NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS SHEATH. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT

  Patient problems: Hematoma

  MAUDE report 8789270 ↗