Model Number M00568401 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported to boston scientific corporation that an endovive standard peg push was used during a gastrostomy replacement procedure on (b)(6) 2022.At the time of the passage of the tube through the orifice the tube detached.The procedure was not completed due to this event.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 a0501captures the reportable event of feeding tube detached.Block h10: one endovive standard peg push was returned.Visual analysis of the device revealed that the thermoformed tubing was detached.Media inspection showed that the pull wire assembly connection broke and one section was lodged inside the tubing.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to procedural and anatomical factors encountered during the procedure; the user technique, patient anatomy or other procedural factors such the incision size and force applied during placement could have broken the pull wire assembly detaching the component from the tubing.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.
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Event Description
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It was reported to boston scientific corporation that an endovive standard peg push was used during a gastrostomy replacement procedure on (b)(6) 2022.At the time of the passage of the tube through the orifice the tube detached.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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