SNARE

Description of Event or Problem

IN ACCORDANCE WITH TITLE 21 PART 803, SUBPART B, 803.22 (B)(2), THIS LETTER IS TO NOTIFY AND PROVIDE YOU THE INFORMATION (B)(6) RECEIVED ON 17JAN2025 WHICH REPORTED THAT DURING A LEAD EXTRACTION PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED WHEN THE PHYSICIAN WAS SNARING FROM THE GROIN. A STERNOTOMY WAS PERFORMED AND A PERFORATION IN THE SUPERIOR VENA CAVA (SVC) WAS DISCOVERED AND REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. THERE WAS ALSO A RIGHT VENTRICULAR (RV) LEAD PRESENT IN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH AT THE POCKET, THE LEAD STARTED TO COME APART. THEN, MOVING TO THE GROIN, SNARING WAS ATTEMPTED AND THE LEAD BROKE. THE PATIENT'S BLOOD PRESSURE THEN BEGAN TO DROP, AND AN EFFUSION WAS DETECTED. STERNOTOMY WAS PERFORMED AND A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED AND REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. ALTHOUGH SPECTRANETICS DEVICES WERE USED DURING THE LEAD EXTRACTION, THE GLIDELIGHT AND TIGHTRAIL WERE NOT BEING USED WHEN THE INJURY OCCURRED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5168093.