BRITE TIP 401011MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032000116), received between Sep 19, 2017 and Dec 11, 2019 — classified as 2 malfunctions.

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

• MalfunctionDec 11, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 10F 11CM BRITE TIP CATHETER SHEATH INTRODUCER WAS USED WHEN AN UNKNOWN COVER STENT WAS IMPLANTED. HOWEVER, THE DISTAL END OF THE BRITE TIP GOT FRAYED WHEN IT WAS INSERTED. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE TARGET LESION WAS THE ILIAC ARTERY. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO CALCIFICATION OF THE LESION, NO VESSEL TORTUOSITY BUT WITH 100% STENOSIS. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE AND DURING PREP. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN NEW SHEATH. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9452290 ↗
• MalfunctionSep 19, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE BRITE TIP SHEATH WAS OPENED IN THE STERILE FIELD. UPON PREPPING THE DEVICE, THE DILATOR WAS UNABLE TO BE ADVANCED INTO THE SHEATH DUE TO THE HEMOSTATIC VALVE HAVING MIGRATED INTO THE LUMEN. THERE WAS NO PATIENT INJURY. THE SHEATH INTRODUCER WAS REPLACED WITH ANOTHER BRITE TIP AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DAMAGES NOTED TO THE PACKAGING. THERE WERE NO DAMAGES NOTED TO THE DEVICE PRIOR TO PREP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6876355 ↗