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Model Number M00558610 |
Device Problems
Burst Container or Vessel (1074); 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 07/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
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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 common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, the patient was undergoing choledocholithiasis extraction and was dilated with cre; however, the balloon burst at 3 pa.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of balloon burst.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 balloon (distal section), located approximately 65 mm from the tip.Microscopic inspection found a pinhole located approximately at 65 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 the 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 in the balloon 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/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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Event Description
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It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the patient was undergoing choledocholithiasis extraction and was dilated with cre; however, the balloon burst at 3 pa.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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