Model Number M00558380 |
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 08/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.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 a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2023.During the procedure, the balloon burst and started leaking fluid.The customer stated that no pieces of the balloon detached inside the patient.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
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Event Description
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It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6)2023.During the procedure, the balloon burst and started leaking fluid.The customer stated that no pieces of the balloon detached inside the patient.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
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Manufacturer Narrative
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H10: block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h10: investigation results: the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon had no damages, and the catheter was kinked in several sections.Microscopic examination was performed and confirmed that the catheter was kinked in several sections.Functional analysis was performed, and the balloon was inflated and able to hold pressure without any problem.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 returned device was in good condition with the capability of being inflated and holding pressure without evidence of leaking.There was no evidence of any damages or issues that would indicate a problem with the device.Therefore, the most probable root cause is no problem detected.
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Search Alerts/Recalls
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