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 07/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block e1: this event was reported by the distributor.The physician is unknown.(b)(6).Block h6 (device codes): imdrf 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 percutaneous endoscopic gastrostomy replacement procedure performed on (b)(6) 2023.On (b)(6) 2023, when cleaning the peg tube, the bolster detached.Reportedly, the detached portion will be excreted.A new endovive securi-t replacement bolster was placed.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block e1: this event was reported by the distributor.The physician is unknown.(b)(6).Block h6 (device codes): imdrf device code a0501 captures the reportable event of internal bolster detached.Block h10: an endovive securi-t replacement bolster was analyzed.Visual analysis of the device revealed that the feeding tube has the bolster detached and the device 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.Block h11 (correction): block g4 combination product has been updated to yes.
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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 percutaneous endoscopic gastrostomy replacement procedure performed on (b)(6) 2023.On (b)(6) 2023, when cleaning the peg tube, the bolster detached.Reportedly, the detached portion will be excreted.A new endovive securi-t replacement bolster was placed.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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