SCANLAN VASCULAR TUNNELER AND BULLET TIP

Additional Manufacturer Narrative

THE RETURNED DEVICE WAS INSPECTED. THE BULLET TIP WAS REMOVED AND THEN REASSEMBLED TO THE SHEATH. IT FIT INTO THE SHEATH WITHOUT FALLING OUT, BUT IT WAS A LOOSE FIT. THIS COULD BE ATTRIBUTED TO ALREADY BEING ASSEMBLED, DISASSEMBLED, AND REASSEMBLED. ASSEMBLING AND DISASSEMBLING THE BULLET TIP FROM THE SHEATH CAN CAUSE THE SHEATH TO WIDEN, THEREFORE LOOSENING THE INTERFERENCE FIT WITH THE BULLET TIP. REVIEW OF THE DESIGN, MANUFACTURING BATCH RECORDS, AND TECHNICAL DOCUMENTATION FOUND NO NON-CONFORMITIES. INSPECTION OF PRODUCT OF ANOTHER PRODUCTION LOT FOUND THE TUNNELER SHEATHS AND BULLET TIPS MEET SPECIFICATIONS AND PERFORM AS INTENDED. THE IFU CAUTIONS USERS THAT CARE MUST BE TAKEN TO ENSURE THE BULLET TIP DOES NOT BECOME DISLODGED DURING THE TUNNELING PROCEDURE. NO EVIDENCE OF PRODUCT NON-CONFORMITY.

Description of Event or Problem

EMAIL RECEIVED REPORTED: 9009-18 BECAME FAULTY DURING A CASE; STATING BULLET TIP HAD A LOOSE FIT AND BECAME DISCONNECTED, AND THE SURGEON HAD TO FISH IT OUT OF THE PATIENT.