Description of Event or Problem · 1
PROGLIDE MISFIRED AT BEGINNING OF SCHEDULED ENDOVASCULAR THORACIC INJURY REPAIR; AT END OF PROCEDURE, SURGEON COULD DETECT NORMAL FLOW IN RIGHT COMMON FEMORAL ARTERY; SURGEON OPENED RIGHT FEMORAL ARTERY AND IDENTIFIED A PIECE OF MATERIAL THAT LIKELY BROKE OFF OF ONE OF THREE PROGLIDE DEVICES USED DURING PROCEDURE; ALL THREE PROGLIDES RETAINED WITH PACKAGING AND FOREIGN BODY AND PLACED IN VASCULAR SERVICES ASSISTANT NURSE MANAGER'S (ANM) OFFICE. DICTATION REPORT READ: "THIS(B)(6) YR OLD FEMALE WAS A TRANSFER FROM ANOTHER HOSPITAL W/ A THORACIC INJURY S/P MVC. TAKEN EMERGENT TO OR FOR THORACIC ENDOSTENT. BEGAN WITH PERCUTANEOUS ENTRY IN GROIN FOR SHEATH PLACEMENT. STENT DEPLOYMENT COMPLETE, HE BEGAN CLOSING PERCUTANEOUS SITE USING PERCLOSE DEVICE. THE FIRST DEVICE MISFIRED MAKING A LOUD POP. HE THEN USED TWO MORE DEVICES TO CLOSE ARTERY. ASSESSING PULSES BEFORE PUTTING ON DRESSING, NO PULSE IN FEMORAL ARTERY OR FEET. HE DID A CUTDOWN TO EVALUATE THE ARTERY AND NOTED IT TO BE COMPLETELY CLOSED OFF (BY THE PERCLOSE STITCH). HE OPENED UP THE ARTERY AND FOUND A SMALL PLASTIC ANCHOR WHICH HE SUSPECTS WAS LEFT FROM THE FIRST PERCLOSE MISFIRING. THIS INJURED THE ARTERY BEYOND HIS ABILITY TO REPAIR. HE HAD TO RESECT THAT PART OF ARTERY AND REPLACE WITH A SYNTHETIC PTFE (GORE) GRAFT. UPON CLOSURE, PULSES WERE PRESENT IN FEET WITH GOOD DOPPLER SIGNALS." MESSAGE HAS BEEN LEFT WITH REP RE: THIS MALFUNCTION OF DEVICE. LOT NUMBERS 6121442, 7040341. PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM. THREE PROGLIDES AND THREE OTHER DEVICE IDENTIFIER # (B)(4).