TightRail Guardian 575-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132027445), received between Feb 16, 2023 and Mar 9, 2023 — 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.

• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS NO LONGER REPORTABLE FOR THE TIGHTRAIL GUARDIAN DEVICE CAUSING OR CONTRIBUTING TO AN ADVERSE EVENT REQUIRING INTERVENTION. AFTER FURTHER REVIEW AND PHYSICIAN ASSESSMENT, IT WAS DETERMINED THAT SNARING IS A STANDARD ADJUNCTIVE TECHNIQUE IN LEAD EXTRACTION PROCEDURES, NOT CONSIDERED ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518299 ↗
• DeathFeb 16, 2023Adverse 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 FRACTURE/MALFUNCTION AND RECALL. A LEFT VENTRICULAR (LV) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT TARGETED FOR EXTRACTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN BEGAN BY USING A SPECTRANETICS 13F TIGHTRAIL GUARDIAN MOTORIZED DILATOR SHEATH TO ATTEMPT REMOVAL OF THE RA LEAD, BUT MALFUNCTIONED. EFFORTS SWITCHED TO ATTEMPT REMOVAL OF THE RV LEAD USING ANOTHER 13F TIGHTRAIL GUARDIAN WITH ITS OUTER SHEATH. LEADS WERE BOUND TOGETHER WITH SIGNIFICANT ADHESIONS UNDER THE CLAVICLE, AND WERE EMBEDDED INTO THE WALL OF THE SUPERIOR VENA CAVA (SVC). BASED ON THE SURGEON'S ASSESSMENT, THE SVC WAS STENOSED DUE TO SCAR TISSUE. ADVANCEMENT WAS MADE TO THE RV'S DISTAL COIL, APPROXIMATELY 6 CM FROM THE LEAD'S TIP, WITH THE OUTER SHEATH POSITIONED MIDWAY ON THE RV COIL NEAR THE TRICUSPID VALVE, WHEN THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, BYPASS AND STERNOTOMY. A CONTINUOUS PERFORATION WAS DISCOVERED FROM THE INNOMINATE VEIN, THROUGH THE SVC AND INTO THE RA.

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Perforation of Vessels

  MAUDE report 16388524 ↗