BRITE TIP 401811MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032000376), received between Mar 14, 2019 and Jul 8, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THERE WAS A MALFUNCTION OF THE SHAFT OF THE 8F 11 CM BRITE TIP CATHETER SHEATH INTRODUCER. THE SHEATH HUB WAS SHEARED OFF WHEN EXCHANGING TO THE INITIAL 8F SHEATH STARTED WITH THE CASE WHICH WAS REPORTED AS AN ABLATION PROCEDURE. THE ISSUE WAS NOTICED WHEN REMOVING THE EXCHANGE WIRE DURING USE IN THE PATIENT. THE DAMAGE WAS DESCRIBED AS FRAYED AND SPLIT IN 2 PIECES. ANOTHER UNKNOWN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689253 ↗
• InjuryJun 10, 2024Material Frayed; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Frayed; Detachment of Device or Device Component; Material Split, Cut or Torn

  AS REPORTED, THE 8F 11CM BRITE TIP SHEATH SNAPPED WHILE INSIDE PATIENT. THE 8F SHEATH RUPTURED INTRAVASCULARLY. THE SHEATH WAS EVENTUALLY RETRIEVED PERCUTANEOUSLY VIA LFV, USING A BALLOON TO PULL IT OUT. ALSO TRIED SNARE BUT WAS NOT AVAILABLE. THE DEVICE WAS STORED IN THE LAB WHILE IN THE SHEATHS CUPBOARD. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THE DEVICE WAS DROPPED ASEPTICALLY IN THE STERILE FIELD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED WHILE FLUSHING THE DEVICE. THE RIGHT FEMORAL VEIN WAS USED FOR ACCESS. THE ACCESS SITE WAS NOT PRE-DILATED. THERE WAS NO RESISTANCE WHILE ADVANCING THE CATHETER THROUGH THE SHEATH. THE SHEATH WAS NOT TORQUED AGAINST RESISTANCE. EXCESS FORCE WAS NOT USED DURING THE PROCEDURE. THERE WAS NO DIFFICULTY TRACKING THROUGH THE VASCULATURE. ATRIAL FLUTTER ABLATION WAS THE INTENDED PROCEDURE. THE DEVICE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497941 ↗
• MalfunctionOct 14, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 8F 11CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS ATTEMPTED TO BE INSERTED INTO BLOOD VESSEL. HOWEVER, IT WAS NOT SMOOTH DUE TO STEP. INSERTION WAS ATTEMPTED SEVERAL TIMES BUT THE DISTAL END GOT FRAYED. THE BRITE TIP WAS REPLACED WITH ANOTHER UNKNOWN SAME SIZED SHEATH, INSERTION WAS DONE AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610867 ↗
• InjuryMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN A PATIENT WITH RIGHT ANTERIOR CEREBRAL ARTERY OCCLUSION WAS IN THE ANGIOGRAPHIC ROOM, A RIGHT FEMORAL SI BRITE TIP 8F 11CM STR CATHETER SHEATH INTRODUCER WAS POSITIONED TO PERFORM CEREBRAL ANGIOGRAPHY AND POSSIBLE THROMBECTOMY. THE INTRODUCER WAS FIXED TO THE SKIN WITH SUTURES AND LEFT IN PLACE. AT SUBSEQUENT NURSING CHECKS, THE INTRODUCER WAS CORRECTLY POSITIONED UNTIL THE FOLLOWING DAY. AT THAT POINT THE PATIENT PRESENTED WITH SUDDEN DESATURATION AND HYPOTENSION WITH MAXIMUM HEMORRHAGE IN THE RIGHT GROIN. THE PATIENT WAS UNCONSCIOUS; THE GLASGOW COMA SCALE 3(GCS 3), GASPING AND PULSELESS ELECTRICAL ACTIVITY (PEA). CARDIOPULMONARY RESUSCITATION WITH EXTERNAL CARDIAC MASSAGE WAS PERFORMED, MASKED VENTILATION AND SUBSEQUENT ORO-TRACHEAL INTUBATION, VOLEMIC EXPANSION WITH COLLOIDS AND CRYSTALLOIDS, ADRENALINE AND BLOOD TRANSFUSION ADMINISTRATION WERE STARTED. THE INTRODUCER WAS REMOVED. CIRCULATION RECOVERY WAS OBSERVED AFTER APPROXIMATELY TEN MINUTES. ONCE THE PATIENT WAS HEMODYNAMICALLY STABLE, THE ABSENCE OF THE CAP OF THE INTRODUCER WAS FOUND IN THE BED. THE DEVICE WAS STORED IN THE CATH LAB IN THE ORIGINAL PACKAGING, HANGING FROM RACKS. THE DEVICE WAS STORED, H

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular System (Circulation), Impaired

  MAUDE report 8422077 ↗