Model Number M00509030 |
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 05/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block b3 (date of event): date of event was approximated to (b)(6) 2023 as no event date was reported.Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.
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Event Description
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It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.It was reported that, during device placement, the peg tube tore apart.Reportedly, air leaked into the peritoneum requiring an angiocath to be inserted to release that air.The procedure was completed with a non-bsc device.
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Event Description
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It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.It was reported that, during device placement, the peg tube tore apart.Reportedly, air leaked into the peritoneum requiring an angiocath to be inserted to release that air.The procedure was completed with a non-bsc device.
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Manufacturer Narrative
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Block b3 (date of event): date of event was approximated to 01may2023 as no event date was reported.Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.Block h10: an endovive safety peg kit push method was analyzed.Visual analysis of the device found that the peg tube separated from the introducer dilator tubing at the joint between the parts.In addition, the returned tubing was necked thin at the joint.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to operational factors, such as technique/handling, patient anatomy, the size of the incision site that the tube was being pulled through and an excessive force used during placement that stretched the tubing could have contributed to the reported complaint.In addition, an evidence to support this scenario includes product analysis details and by applying force to the introducer dilator tubing cause the material to neck down and thin.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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