BRITE TIP 401835MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032000390), received between Feb 16, 2022 and Feb 16, 2022 — classified as 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 16, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, AFTER REMOVING THE A 8F 35CM STR SI BRITE TIP SHEATH AND THE DISTAL END WAS CHECKED A FRAYED DAMAGE WAS CONFIRMED AT THE TIP PART. THE DAMAGE WAS NOTICED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE SHEATH WAS USED TO REMOVE THE OPTEASE FILTER AND WAS UNSUCCESSFUL. THEREFORE, IT WAS REPLACED WITH A NEW RECOMMENDED UNKNOWN SYSTEM AND THE FILTER WAS REMOVED. ¿REGARDING THE REMOVAL METHOD THIS WAS NOT THE RECOMMENDED, BUT THE DOCTOR DID IT EVEN THOUGH HE KNEW THE RISK OF TROUBLE.¿ THE PRODUCT WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE IN THE LAB. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE ACCESS SITE WAS THE FEMORAL ARTERIES. THE INTENDED PROCEDURE/TARGET LESION WAS THE INFERIOR VENA CAVA FOR FILTER REMOVAL. THERE WAS NO DIFFICULTY TRACKING THROUGH THE VASCULATURE AND NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546796 ↗