SLS II Laser Sheath 500-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132020316), received between Oct 23, 2018 and Nov 4, 2020 — classified as 1 death, 1 injury.

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.

• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A SINGLE COIL RIGHT VENTRICULAR (RV) LEAD IMPLANTED IN 2014. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV TO ACT AS A TRACTION PLATFORM TO AID IN EXTRACTION. THE PHYSICIAN BEGAN THE CASE USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH. HE WAS ABLE TO PROGRESS TO THE SUBCLAVIAN/INNOMINATE REGION, AND THEN, DUE TO ADHESIONS, HE CHOSE TO USE A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH. AT THIS TIME, THE LEAD LOOKED LIKE IT WAS BREAKING APART AND THE PHYSICIAN CHOSE TO USE A SPECTRANETICS 16F SLS DEVICE. AT THAT TIME THE PATIENT HAD DROP IN BLOOD PRESSURE. IT WAS FIRST THOUGHT THAT THE RV WAS BEING INVERTED DURING TRACTION, BUT PRESSURE CONTINUED TO DROP WHEN TRACTION WAS RELEASED. CONTRAST WAS USED TO CONFIRM THE INJURY LOCATION; AN INNOMINATE INJURY, 1CM IN LENGTH, WAS DISCOVERED, 4-5CM LATERAL TO THE SUPERIOR VENA CAVA (SVC). RESCUE EFFORTS COMMENCED IMMEDIATELY, INCLUDING STERNOTOMY. THE REPAIR TO THE INNOMINATE VEIN WAS SUCCESSFUL, AND THE PATIENT SURVIVED THE PROCEDURE. THE RV LEAD WAS REMOVED WITHOUT ISSUES POST-STERNOTOMY, WITH USE OF THE 16F SLS DEVICE. THERE WAS NO ALLEGED MALFUNCTION OF ANY S

  Patient problems: Iatrogenic Source; Perforation of Vessels

  MAUDE report 10784931 ↗
• DeathOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT A CARDIAC LEAD MANAGEMENT PROCEDURE TO REMOVE A RIGHT VENTRICULAR (RV) LEAD COMMENCED ON (B)(6) 2018. THE SPECTRANETICS SLS II LASER SHEATH 500-013 WAS UTILIZED TO EXTRACT THE LEAD WITHOUT ISSUE. THE PHYSICIAN THEN PUT A GUIDEWIRE IN THROUGH THE SLS LASER SHEATH FOR RE-IMPLANT OF AN ADDITIONAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD. AS THE LEAD WAS PLACED, THE PATIENT'S BLOOD PRESSURE BEGAN TO SLOWLY DROP DOWN INTO THE 40S. RESCUE EFFORTS WERE IMPLEMENTED. AFTER STERNOTOMY WAS COMPLETED, THE PHYSICIAN CONFIRMED THERE WAS A TEAR IN THE INNOMINATE VEIN. THEY CONTINUED WITH THE SURGICAL RESCUE BUT THE PATIENT DID NOT SURVIVE THE PROCEDURE.

  Patient problems: Death; Iatrogenic Source; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 7997540 ↗