Model Number M00509161 |
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 03/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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Device codes: device code a0501 captures the reportable event of internal bolster detached.
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Event Description
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It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a gastrostomy catheter replacement procedure performed on(b)(6) 2023.When attempting to remove the placed device the bumper separated and was left inside the patient.It was retrieved through an endoscope.The procedure was completed with a new endovive securi-t replacement bolster.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a gastrostomy catheter replacement procedure performed on (b)(6) 2023.When attempting to remove the placed device the bumper separated and was left inside the patient.It was retrieved through an endoscope.The procedure was completed with a new endovive securi-t replacement bolster.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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(device codes): imdrf device code a0501 captures the reportable event of internal bolster detached.An endovive securi-t replacement bolster was analyzed.Visual analysis of the device revealed that the feeding tube has the bolster detached and traces of adhesion in the distal end of the feeding tube.Media inspection showed the internal bolster detached and has remnants of use.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to excessive stress, manipulation or anatomical conditions of the patient could have contributed to the separation.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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Search Alerts/Recalls
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