16F SLS SPECTRANETICS CORP.

INDICATION FOR PROCEDURE: ICD LEAD FRACTURE. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE PERFORMED IN THE LAB, 1 LEAD TO BE REMOVED (ACTIVE RV LEAD, IMPLANTED IN 2004). THIRTY MINUTES INTO THE PROCEDURE, THE MD WAS HAVING DIFFICULTY ADVANCING THE 16F SLS FROM THE SVC TO THE RA DUE TO THE AREA BEING HIGHLY FIBROSED. THE MD WAS ABLE TO SUCCESSFULLY PASS THIS AREA BUT FELT THE LEAD "POP". THE PATIENT'S VITAL SIGNS WERE WITHOUT CHANGE, BUT THE MD ORDERED A STAT FLUOROSCOPY TO VISUALIZE THE PATIENT'S HEART AND LUNGS. A CARDIAC TAMPONADE WAS SEEN AND THE PATIENT'S HEART RATE BEGAN DECREASING. THE CT SURGEON WAS CONTACTED, A STERNOTOMY PERFORMED AND A "4 INCH SVC TEAR" DISCOVERED. ANALYSIS: THE DEVICES USED IN THIS CASE WERE NOT RETAINED BY THE HOSPITAL STAFF FOR POST-PROCEDURE ANALYSIS BY THE MANUFACTURER. LOT HISTORY REVIEWS WERE UNABLE TO BE PERFORMED SECONDARY TO DEVICES BEING DISPOSED OF AND HOSPITAL STAFF DID NOT RECORD THIS INFORMATION. PATIENT'S OUTCOME: THE PATIENT EXPIRED.

MANUFACTURE DATES FOR ALL DEVICES: UNK.

INDICATION FOR PROCEDURE: ACUTE INFECTION. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE PERFORMED IN THE O.R., 2 ICD LEADS TO BE REMOVED (PASSIVE RV AND RA LEAD, IMPLANTED IN 2004). RV LEAD WAS REMOVED WITH THE 16F SLS WITHOUT COMPLICATION. AFTER THE RA LEAD WAS REMOVED A NOTED DROP IN THE PT'S BLOOD PRESSURE OCCURRED. CT SURGEON CONTACTED, STAT ECHO WAS PERFORMED, CARDIAC EFFUSION NOTED AND ECHO-GUIDED PERICARDIOCENTESIS WAS PERFORMED BY PRIMARY SURGEON. ANALYSIS: LOT HISTORY REVIEW FOUND NO ISSUES OR NONCONFORMANCES RELATED TO THE REPORTED EVENT. PT OUTCOME: THE PT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL PER PROTOCOL.