VisiSheath Dilator Sheath 501-114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132020392), received between Oct 5, 2018 and Feb 8, 2022 — classified as 2 injuries.

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 18, 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.

• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO RV MALFUNCTION, AND RA NEEDED TO BE REMOVED TO BE MRI COMPATIBLE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED IN BOTH LEADS TO PROVIDE TRACTION. A COOK MEDICAL ONE-TIE COMPRESSION COIL WAS USED ON THE RV LEAD TO PROVIDE ADDITIONAL TRACTION. IT WAS NOTED THAT THE PATIENT WAS OCCLUDED ON THE LEFT SIDE. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH WERE USED TO ATTEMPT REMOVAL OF THE RV LEAD. PROGRESS WAS MADE IN THE VASCULATURE, BUT STALLED IN THE INNOMINATE AREA. THE PHYSICIAN ALTERNATED USE OF THE GLIDELIGHT AND VISISHEATH DEVICES, ULTIMATELY GETTING THROUGH THE BINDING IN THE INNOMINATE/SUPERIOR VENA CAVA (SVC) REGION. ONCE THROUGH THAT AREA, THE RV LEAD CAME FREE WITH TRACTION AND USE OF THE VISISHEATH. NO HEMODYNAMIC CHANGES WERE NOTED AT THE TIME, AND NO COMPLICATIONS WERE SEEN VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PHYSICIAN NOTICED THAT THE 14F GLIDELIGHT WAS SLIGHTLY BENT AT THE TIP OF THE DEVICE AFTER THE GLIDELIGHT DEVICE WAS TOSSED TO THE SIDE WHEN THE TEMPORARY PACING WIRE LOST CAPTURE (SO NO ISSUE W

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 13486240 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD MANAGEMENT CASE COMMENCED TO REMOVE THREE LEADS: RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS DUE TO INFECTION. WITH USE OF A SPECTRANETICS VISISHEATH, A LEAD LOCKING DEVICE (LLD) AND A GLIDELIGHT DEVICE MODEL 500-302, THE LV LEAD WAS SUCCESSFULLY REMOVED FIRST, THEN REMOVAL OF THE RA LEAD WAS ATTEMPTED NEXT. HOWEVER, SIGNIFICANT LEAD ON LEAD BINDING WAS ENCOUNTERED, SO THE PHYSICIAN THEN SWITCHED ATTEMPT TO REMOVE RV LEAD INSTEAD. EXTENSIVE MANIPULATION OF VISISHEATH WAS PERFORMED IN ORDER TO CROSS THE BINDING. THE RV LEAD WAS ULTIMATELY REMOVED WITH SUCCESS; HOWEVER AT THIS TIME PATIENT''S BLOOD PRESSURE DROPPED. RESCUE EFFORTS COMMENCED IMMEDIATELY INCLUDING STERNOTOMY. A TEAR IN THE PATIENT''S INNOMINATE VEIN WAS DISCOVERED. THE REMAINING RA LEAD WAS REMOVED POST STERNOTOMY, REPAIR OF THE INJURY WAS MADE AND PATIENT SURVIVED THE PROCEDURE.

  Patient problems: Hot Flashes/Flushes; Iatrogenic Source

  MAUDE report 7940952 ↗