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 23DEC2025 WHICH REPORTED THAT DURING A LEAD EXTRACTION PROCEDURE, A PERICARDIA! EFFUSION OCCURRED, REQUIRING INTERVENTION. A PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT SURVIVED THE PROCEDURE. A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD. (B)(6) LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. WHEN ADVANCING TO THE TARGET SITE WITH A (B)(6) 16F GLIDELIGHT LASER SHEATH, THE LEAD BROKE IN HALF. THE DECISION WAS MADE TO USE A SNARE (MANUFACTURER UNKNOWN) FROM THE GROIN. AFTER SEVERAL HOURS OF SNARING THE LEAD, A PERICARDIAI EFFUSION WAS DETECTED AND RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND BYPASS. THE PATIENT STABILIZED AND SURVIVED THE PROCEDURE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE SNARE. THE MANUFACTURER OF THIS DEVICE IS UNKNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).