Model Number M00545920 |
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 08/18/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with a stent placement procedure performed on (b)(6) 2023.During the procedure, it was noted that the balloon burst and leaked liquid.The procedure was completed with another hurricane rx 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 h6: imdrf device code a0402 captures the reportable event of a balloon burst.
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Event Description
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It was reported to boston scientific corporation that hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with a stent placement procedure performed on (b)(6) 2023.During the procedure, it was noted that the balloon burst and leaked liquid.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Imdrf device code (b)(4).Captures the reportable event of a balloon burst.Investigation results the returned hurricane rx dilatation balloon was analyzed, and a visual examination found that the balloon torn longitudinally.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.It was observed that the balloon had a longitudinal torn.The balloon torn problem found could have been interpreted by the customer as the reported event of balloon burst.It is possible that during the procedure the device has interacted with some sharp surface or other devices that may have caused the longitudinal torn of the balloon.Perhaps the manipulation, technique used, or patient's anatomical conditions could have also contributed to this event.Therefore, the most probable root cause is adverse event related to procedure.
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Search Alerts/Recalls
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