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Model Number M00558690 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, upon dilation of the distal esophagus, the balloon would not inflate past 7mm.It was reported that the balloon was leaking fluid.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Device code: a0504 captures the reportable event of balloon leaked in the esophagus.
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Search Alerts/Recalls
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