It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2024.During the procedure, the guidewire could not pass through the transition zone between the connector, between the hard and soft plastic.The procedure was completed with a second endovive safety peg kit push method.There were no patient complications reported as a result of this event.
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It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2024.During the procedure, the guidewire could not pass through the transition zone between the connector, between the hard and soft plastic.The procedure was completed with a second endovive safety peg kit push method.There were no patient complications reported as a result of this event.
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Block h6: imdrf device code a1409 captures the reportable event of peg tube obstructed.Block h10: the returned endovive safety peg kit push method was analyzed.Visual inspection noted that there were no problems with the device exterior.A functional test was performed using a 0.035 inch guidewire that was inserted through the entrance of the feeding tube.However, difficulty advancing the guidewire was noted and the guidewire could not pass through the transition joint/barb connector.The barb connector was isolated by cutting the sides of the tubing that it was connecting.Visual inspection of inside the barb connector showed obstruction on the side usually connected to the feeding tube in the form of glue/adhesive.No additional problems with the device were noted.With all the available information, boston scientific corporation (bsc) concludes the reported event of peg tube obstruction was confirmed.The peg tube obstruction was likely caused by adhesive inside the hypo-tube of the transition joint.Adhesive is used during assembly, and it is likely that the obstruction was the result of incorrect placement or excessive use of adhesive, resulting in obstruction of the hypo tube.Therefore, the most probable root cause is manufacturing deficiency.Bsc initiated a corrective and preventive action (capa) investigation to determine the root cause of this problem.The hypo-tube inside the transition joint of the returned device was found to be blocked with adhesive.Investigation identified a potential scenario in which the tip of the glue dispenser touches the threaded tip of the barb as it moves into position for glue and torque at the mini bolster.This could cause glue to migrate into the lumen of the barb component and cause a blockage.An initial containment was implemented on 05dec2023, and the pneumatic flow valve of the equipment was adjusted to ensure that the glue dispenser does not move into position until the barb is in the correct position, preventing the potential for this issue to reoccur.Additional corrections were implemented on 05feb2024 to add 100% pin gage inspection after the mini bolster step for push method device types.An investigation to address this problem has been completed.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
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