EN SNARE®

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT DURING A LEAD EXTRACTION PROCEDURE ON (B)(6) 2024 TO REMOVE A RIGHT ATRIAL (RA) LEAD, A RIGHT VENTRICULAR (RV) LEAD, AND A RIGHT VENTRICULAR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (RV ICD) LEAD, THE RA AND RV LEADS WERE SUCCESSFULLY EXTRACTED USING VARIOUS DEVICES, INCLUDING LEAD LOCKING DEVICES, GLIDELIGHT LASER SHEATHS (14F AND 16F), AND COOK MEDICAL EVOLUTION SHEATHS (11F SHORT AND 13F LONG). WHILE ATTEMPTING TO REMOVE THE RV ICD LEAD, THE LEAD INSULATION APPEARED TO "SNOWPLOW" (BUNCH UP) IN THE SUPERIOR VENA CAVA (SVC) REGION, AND THE LEAD FRACTURED. ADDITIONAL EFFORTS TO RETRIEVE THE FRACTURED LEAD, INVOLVING MULTIPLE DEVICES SUCH AS A BYRD BF OUTER SHEATH, AGILIS STEERABLE INTRODUCER SHEATH, COOK MEDICAL NEEDLE'S EYE SNARE, MERIT MEDICAL EN SNARE ENDOVASCULAR SNARE SYSTEM, AND FORCEPS (MANUFACTURER/TYPE UNKNOWN), RESULTED IN A SECOND FRACTURE OF THE LEAD. ADHESIONS ON THE LEAD'S SVC COIL WERE ADDRESSED USING A 16F GLIDELIGHT SHEATH FROM THE POCKET APPROACH; HOWEVER, THE PATIENT BEGAN BLEEDING. RESCUE EFFORTS, INCLUDING A THORACOTOMY, REVEALED A PERFORATION OF THE INFERIOR VENA CAVA (IVC), WHICH WAS REPAIRED. DESPITE THESE EFFORTS, A PORTION OF THE RV ICD LEAD REMAINED IN THE PATIENT. THE ACCOUNT FURTHER NOTES THAT ALTHOUGH MULTIPLE DEVICES WERE USED DURING THE PROCEDURE, NO DEVICES WERE INVOLVED IN THE IVC, WHERE THE PERFORATION OCCURRED. THE PATIENT SURVIVED THE PROCEDURE.