BRITE TIP 401655MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032000277), received between Dec 8, 2021 and Nov 19, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE DOCTOR FELT RESISTANCE WHEN THE 6F 55CM BRITE TIP SHEATH INTRODUCER WAS INSERTED. THE SHEATH WAS REMOVED AND THE TIP GOT FRAYED. IT WAS REPLACED WITH A NEW BRITE TIP SHEATH (DIFFERENT LOT#) AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE WERE REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730450 ↗
• InjuryOct 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 6F 55CM BRITE TIP SHEATH INTRODUCER DID NOT SLIDE AT THE END OF THE INTERVENTION WHEN REMOVING THE INTRODUCER. THE PHYSICIAN MANAGED TO MAKE IT SLIDE WITH DELICATE AND SLOW MOVEMENTS. THE SHEATH BEGAN TO STRETCH AND FINALLY BECAME BROKEN, LEAVING THE DISTAL PART IN THE PATIENT. FORTUNATELY, USING CHRISTOPHE FORCEPS, THE PHYSICIAN WAS ABLE TO CATCH AND MANAGED TO RECOVER THE MISSING PART OF THE INTRODUCER. THE DEVICE WAS USED IN A CROSS OVER ¿AEL¿ PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978249 ↗
• MalfunctionDec 8, 2021Difficult to Remove; Difficult to Remove

  DURING USE OF THE 6F BRITE TIP CATHETER SHEATH INTRODUCER (CSI), THE PHYSICIAN COULD NOT REMOVE THE SHEATH FROM PATIENT BECAUSE THE SHEATH KINKED. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960561 ↗