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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 12/01/2022 |
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 on (b)(6) 2022.During the procedure, the balloon was inflated to 6 atm; however, it could not maintain inflation and it was noticed that water was coming out of the balloon.The procedure was completed with another cre 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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(b)(4).
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Manufacturer Narrative
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Block h6: device code a0504 captures the reportable event of balloon leak in the esophagus.Block h10: investigation results the returned cre pro wireguided dilatation balloon was analyzed and a visual examination found that the balloon and catheter of the device had no damages.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 body of the balloon.Microscopic inspection found the balloon had a pinhole located approximately 15mm from the tip.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of balloon leak was confirmed.The pinhole found in the balloon is likely to have occurred due to factors encountered during the procedure: interaction with scope and other sharp devices during the procedure could create friction on the balloon and cause a pinhole.Therefore, the most probable root cause is adverse event related to procedure.
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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 on (b)(6) 2022.During the procedure, the balloon was inflated to 6 atm; however, it could not maintain inflation and it was noticed that water was coming out of the balloon.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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