BRITE TIP 401855MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032000413), received between May 16, 2017 and Feb 25, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionFeb 25, 2021Crack; Crack

  DURING THE OPERATION, THE TIP OF AN 8F 55CM STRAIGHT (STR) BRITE TIP SHEATH INTRODUCER WAS DAMAGED (CRACKED), AND AN UNKNOWN FILTER HAS NOT BEEN RECOVERED. THE SURGEON WITHDREW THE BRITE TIP, AND THE PROCEDURE WAS COMPLETED USING A NEW UNKNOWN LONG SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS MILDLY TORTUOUS. THE DEVICE HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. THERE WAS NO EXCESSIVE FORCE USED. THE RESIDUE WAS NOT LEFT IN THE PATIENT¿S BODY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IMAGES ARE AVAILABLE FOR REVIEW. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379882 ↗
• MalfunctionMay 16, 2017Difficult to Insert; Torn Material; Difficult to Insert; Torn Material

  IT WAS REPORTED THAT THE BRITE TIP SHEATH INTRODUCER TIP WAS FRAYED. THE SHEATH WAS REPLACED WITH A NEW BRITE TIP SHEATH AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. A BRITE TIP SHEATH WAS ATTEMPTED TO INSERT INTO A VESSEL BUT THERE WAS RESISTANCE FELT. THE DEVICE WAS REMOVED AND THE DISTAL TIP WAS CONFIRMED TO BE FRAYED. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. NO DAMAGES WERE NOTED TO THE SHEATH. THE DEVICE WAS FLUSHED PRIOR TO INSERTION. THE PRODUCT STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6569185 ↗