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 08/01/2023 |
Event Type
Injury
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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 gastric tube replacement procedure performed on (b)(6) 2023.During the procedure when removing the securi-t that had been previously placed the internal bolster detached.The bolster was retrieved with an endoscope and 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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Block h6 (device codes): imdrf device code a0501 captures the reportable event of internal bolster detached.Block h6 (impact codes): imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2301 captures the reportable event of additional device required.
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Manufacturer Narrative
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Block h6 (device codes): imdrf device code a0501 captures the reportable event of internal bolster detached.Block h6 (impact codes): imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2301 captures the reportable event of additional device required.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 gastric tube replacement procedure performed on (b)(6) 2023.During the procedure when removing the securi-t that had been previously placed the internal bolster detached.The bolster was retrieved with an endoscope and 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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Search Alerts/Recalls
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