BRITE TIP 401711MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705032000307), received between Oct 19, 2020 and Jun 26, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 7F 11 CM BRITE TIP CATHETER SHEATH INTRODUCER WAS SORT OF "DENTED" AND IT WAS NOT POSSIBLE TO INTRODUCE THE SHEATH WHEN CHANGING A 6F UNKNOWN SHEATH TO A 7F SHEATH EVEN THOUGH IT WAS A RATHER YOUNG PATIENT WITHOUT A LOT OF PLAQUE. THE DEVICE COULD NOT BE INTRODUCED INTO THE VESSEL. A NEW 7F BRITE TIP SHEATH WAS USED AND WORKED WELL. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND IT WAS PREPPED WITH NO DIFFICULTY. THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. SLIGHTLY MORE THAN USUAL FORCE WAS REQUIRED IN ORDER TO POSITION THE SHEATH. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616632 ↗
• MalfunctionJan 6, 2023Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, THE MINI GUIDEWIRE OF A 7F 11CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) UNRAVELED WHILE IN PATIENT. FORTUNATELY, THE WIRE WAS ABLE TO BE RETRIEVED BEFORE IT BROKE OFF IN THE PATIENT. THERE WAS NO LEFTOVER MATERIAL IN THE BODY. THE ISSUE WAS NOTED WHEN THEY HAD DIFFICULTY ADVANCING THE WIRE. THE PROCEDURE WAS COMPLETED NORMALLY AFTER WIRE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAS A HISTORY OF PAROXYSMAL A-FIB. THE DEVICE WAS KEPT IN OUR STOREROOM THAT IS KEPT AT AN ACCEPTABLE TEMPERATURE AND HUMIDITY. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. WIRE WAS REMOVED FROM THE PACKAGING BY THE BACK END OF THE WIRE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). RIGHT FEMORAL VENOUS ACCESS FOR SHEATH PLACEMENT DURING AN ELECTROPHYSIOLOGY (EP) STUDY. THE LESION WAS NOT CALCIFIED. THERE WAS LITTLE VESSEL TORTUOSITY AND VESSEL ANGULATION. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117941 ↗
• MalfunctionSep 12, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, AFTER A PUNCTURE WAS MADE, THERE WAS DIFFICULTY INSERTING A 7F 11CM STRAIGHT BRITE TIP CATHETER SHEATH INTRODUCER (CSI) INTO THE PATIENT. AFTER MULTIPLE ATTEMPTS BY THE PHYSICIAN TO INSERT THE 7F BRITE TIP CSI, THE DISTAL PORTION OF THE CSI BECAME FRAYED. AS A RESULT, A 7F NON-CORDIS CSI WAS USED IN PACE OF THE BRITE TIP CSI TO CONTINUE THE PROCEDURE. THERE WAS NO VESSEL TRAUMA CAUSED TO THE PATIENT AS A RESULT OF THE MALFUNCTION, AND NO OTHER PATIENT INJURIES WERE REPORTED. IT WAS REPORTED THAT THE GAP BETWEEN THE CSI AND THE DILATOR WAS CAUSING THE INSERTION DIFFICULTY. THE RIGHT FEMORAL ARTERY WAS ACCESSED FOR THIS PROCEDURE. THERE WAS MILD CALCIFICATION AND MILD TORTUOSITY TO THE ACCESS VESSEL. HOWEVER, THERE WAS NO STENOSIS OR STENTS PLACED WITHIN THE ACCESS VESSEL. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY PREPPING THE DEVICE. THERE WAS NO DIFFICULTY INSERTING THE DILATOR INTO THE BRITE TIP CSI, AND NO DAMAGE WAS OBSERVED TO THE CSI PRIOR TO USE. SALINE WAS SUED TO WET THE DEVICE PRIOR TO ITS ATTEMPTED INSERTION. ADDITIONALLY, THERE WAS NO SEPARATION OF THE DEVICE OBSERVED. THE DEVICE HAS BEEN DISCARDED AND W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407145 ↗
• MalfunctionJan 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE ROTATING HEMOSTATIC VALVE OF A 7F 11CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS "RELEASED EASILY" WHEN THE SHEATH WAS INSERTED. THE DEVICE WAS REPLACED WITH ANOTHER BRITE TIP SHEATH. THE PROCEDURE AND VASCULAR CLOSURE WITH THE HEMOSTASIS PLUG WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE SHEATH WAS USED WITH A CORDIS EXOSEAL DEVICE FOR CLOSURE AFTER AN ENDOVASCULAR THERAPY (EVT) CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167515 ↗
• MalfunctionDec 14, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 7F 11CM STRAIGHT (STR) BRITE TIP SHEATH INTRODUCER WAS INSERTED BUT THE DISTAL END GOT FRAYED. THEREFORE, IT WAS REPLACED WITH ANOTHER BRITE TIP SHEATH WITH THE SAME LOT AND IT WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002407 ↗
• MalfunctionOct 19, 2020Material Frayed; Material Frayed

  AS REPORTED, A 7F 11CM STRAIGHT (STR) BRITE TIP SHEATH INTRODUCER WAS INSERTED; BUT THE DISTAL END GOT FRAYED. THEREFORE, IT WAS NOT USED FOR THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10697793 ↗