BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Model Number M00566470 |
Device Problems
Obstruction of Flow (2423); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Event Description
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Note: this report pertains to the first of four endovive safety peg kits push method used during the same procedure in the same patient.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.It was reported that during tube placement, the guidewire would not pass through the transition zone between the connector of the peg tube.The same problem occurred with three more peg tubes.The procedure was completed with a pull method device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.
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Event Description
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Note: this report pertains to the first of four endovive safety peg kits push method used during the same procedure in the same patient.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.It was reported that during tube placement, the guidewire would not pass through the transition zone between the connector of the peg tube.The same problem occurred with three more peg tubes.The procedure was completed with a pull method device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.Block h10: the customer reported that the device was disposed and will not be returned.As such, physical analysis has not been conducted in our laboratory.However, a device history review was performed and determined that, based on the nature of the reported event and the reported device lot number, the peg tube obstruction was likely the result of the manufacturing process.With all the available information, although the device has not been returned, boston scientific corporation (bsc) determined that 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.Bsc initiated a corrective and preventive action (capa) investigation to determine the root cause of this issue.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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Manufacturer Narrative
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Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.Block h10: the customer reported that the device was disposed and will not be returned.As such, physical analysis has not been conducted in our laboratory.However, a device history review was performed and determined that, based on the nature of the reported event and the reported device lot number, the peg tube obstruction was likely the result of the manufacturing process.With all the available information, although the device has not been returned, boston scientific corporation (bsc) determined that 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.Bsc initiated a corrective and preventive action (capa) investigation to determine the root cause of this issue.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 (b)(6) 2023, 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 (b)(6) 2024 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.Block h11 (correction): block h6 (device codes) has been corrected.
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Event Description
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Note: this report pertains to the first of four endovive safety peg kits push method used during the same procedure in the same patient.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.It was reported that during tube placement, the guidewire would not pass through the transition zone between the connector of the peg tube.The same problem occurred with three more peg tubes.The procedure was completed with a pull method device.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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