Model Number ES-330 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Perforation of Esophagus (2399)
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Event Date 05/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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Datafiles showing the time course of the dilation and lumen diameter measurements were reviewed with the physician who performed the cases.The case showed a narrowing proximal to the gastroesophageal junction which, it is postulated, may not have been able to tolerate the 30 mm diameter dilation.Datafiles from the case show that no malfunction of the endoflip system or esoflip balloon dilation catheter occurred.Furthermore, biomedical engineering at the hospital successfully completed a functional check of the pump 6/12/2017 to verify the system.The most probable root cause of this event is anticipated procedural complication as the reported event is a known physiological effect of the procedure (aliment pharmacol ther 2011;34:832-9).
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Event Description
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It was reported to crospon that an esoflip es-330 balloon dilation catheter was used in a 30 mm achalasia dilation procedures which resulted in esophageal perforation.The perforation was not detected during the procedure, but became evident during subsequent testing with gastrograffin.The perforation was treated with surgery, and the patient has been discharged.
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Manufacturer Narrative
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Follow up report to include data submitted by user facility to fda under importer report number (b)(4).
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Event Description
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Follow-up report submitted to add user facility report number.
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Search Alerts/Recalls
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