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Model Number M00545900 |
Device Problems
Burst Container or Vessel (1074); Use of Device Problem (1670); 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 09/01/2023 |
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 device code a0402 captures the reportable event of balloon burst.
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Event Description
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Note: this report pertains to one of two hurricane rx dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two hurricane rx dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Prior to the procedure, the balloon burst.The second hurricane rx dilatation balloon used burst during the procedure.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
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Event Description
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Note: this report pertains to one of two hurricane rx dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two hurricane rx dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Prior to the procedure, the balloon burst.The second hurricane rx dilatation balloon used burst during the procedure.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
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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 device code a0402 captures the reportable event of balloon burst.Block h10: investigation results the returned hurricane rx 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 15 mm from the tip.Microscopic inspection found a pinhole located approximately at 15 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 burst cannot be 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 or interaction with other devices.Also, it is possible that interaction with a sharp surface during/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.A labeling review was performed, and from the information available, this device was not used in accordance with the instructions for use (ifu)/product label.
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Search Alerts/Recalls
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