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Model Number M00558380 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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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 an unknown date.During the procedure, the balloon would not completely deflate.The syringe was then removed from the balloon, and the water inside was discarded.The syringe was reattached to the inflator, but the balloon would still not deflate.The device was removed with the scope from the patient, and the device was cut in order to be removed from the scope.The procedure was completed with another cre fixed wire 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 b3: date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Block h6: device code a1401 captures the reportable event of balloon failed to deflate.Block h10: investigation results: a visual examination of the returned complaint device found that the catheter was detached in two sections.It was also noted that the catheter was kinked and was cut.The balloon was carefully inspected and no damages were found.Microscopic analysis was performed, and it was confirmed that the catheter was kinked and was cut.Diameter (od) of the catheter, and was measured in three sections; distal, medium and proximal.The three sections were within specification.The reported event of balloon failed to deflate was confirmed based on the found failure of catheter kinked which probably affected the deflation time thus, the device had to be cut.This failure is likely due to factors encountered during the procedure, such as the interaction between the device with the scope, and normal procedural difficulties encountered during the procedure could have possibly affected the device performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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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 an unknown date.During the procedure, the balloon would not completely deflate.The syringe was then removed from the balloon, and the water inside was discarded.The syringe was reattached to the inflator, but the balloon would still not deflate.The device was removed with the scope from the patient, and the device was cut in order to be removed from the scope.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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