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Model Number M00558650 |
Device Problems
Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf code a041001 captures the reportable event of a balloon pinhole in the esophagus.
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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 an unknown date.During the procedure, when the balloon was attempted to be inflated, they noticed that the balloon was not holding pressure and was spraying the water.A video submitted by the customer showed that a balloon had a pinhole, causing the balloon to leak.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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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 an unknown date.During the procedure, when the balloon was attempted to be inflated, they noticed that the balloon was not holding pressure and was spraying the water.A video submitted by the customer showed that a balloon had a pinhole, causing the balloon to leak.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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Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf code a041001 captures the reportable event of a balloon pinhole in the esophagus.Block h10: investigation results: the returned cre pro wireguided dilatation balloon was analyzed, and a visual examination found that the catheter of the device was kinked.No damages were found in the balloon of the device.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure due to a pinhole in the balloon (distal section), located approximately 16 mm from the tip.Microscopic inspection found a pinhole located approximately at 16 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of a balloon pinhole was confirmed.The results of the analysis performed on the returned device along with the video provided by the customer showed that there is a pinhole located approximately at 16 mm from the tip of the device.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous the procedure, could have caused the problem found on the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
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Search Alerts/Recalls
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