BRITE TIP 401745MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032000338), received between Jun 11, 2019 and Jul 8, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryJul 8, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  AS REPORTED, A 7F STR BRITE TIP CATHETER SHEATH INTRODUCER (CSI) KINKED IN "THE BIFURCATION MASSIVELY". IT WAS "HEAVY" TO PULL THE DEVICES OUT, WITH THE HANDLING THE BRITE TIP CSI EXPANDED NEAR THE KINK. THE MATERIAL "GOT LESS" (COLOR GOT MORE TRANSPARENT) AND BECAME SOFTER. THE PHYSICIAN WAS AFRAID, THAT THE SHEATH COULD TEAR OFF. HE NEEDED A LOT OF "MATERIAL" TO PULL THE SHEATH OUT. THE WAY FOR THIS SUCCESS WAS, TO INFLATE A .018 SABER BALLOON CATHETER IN THE NEAR OF THE TIP OF THE SHEATH AND PULL THE BALLOON AND THE SHEATH TOGETHER OUT OF THE PATIENT. THE PATIENT WAS NOT HARMED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE SHEATH WAS IN PLACE FOR 15 MINUTES. THE SHEATH WAS NOT USED FOR ANY INFUSIONS OTHER THAN CONTRAST MEDIA. THE PROCEDURE WAS AN ENDOVASCULAR TREATMENT OF STENOSIS OF THE LEFT LEG. THE PROCEDURE USED A CROSSOVER FROM THE COMMON FEMORAL ARTERY INTO THE RIGHT EXTERNAL AND COMMON ILIAC ARTERY, ENDING IN THE LEFT COMMON ILIAC ARTERY ( WHICH WAS COVERED WITH AN OLD NITINOL STENT). THE VESSEL WAS SEVERELY CALCIFIED, MILDLY TORTUOUS, WITH MILD STENOSIS AND MODERATE BIFURCATION. THE FIRST TREATMENT WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959637 ↗
• MalfunctionJun 11, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A BRITE TIP 7F 45CM STR SHEATH INTRODUCER WAS USED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), HOWEVER; THE TIP OF THE BRITE TIP SHEATH WAS BROKEN WHEN IT WAS INSERTED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE PRODUCT ANALYSIS WHICH STATED, THAT THE BRITE TIP WAS OBSERVED TORN/SPLIT ON THE DISTAL AREA. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS REPLACED WITH ANOTHER BRITE TIP SHEATH AND IT WAS INSERTED WITHOUT ANY ISSUES. THE DEVICE WAS STORED WITH THE OTHER DEVICES. THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689251 ↗