It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the superior lobe of right lung during a balloon dilation procedure performed on august 1, 2023.During the procedure, the balloon burst when pressure was applied to 10 mm.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h10: investigation results: the returned cre pulmonary 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 balloon (distal section), located approximately 41 mm from the tip.Microscopic inspection found a pinhole located approximately at 41 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 balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.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 distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
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