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Model Number M00558370 |
Device Problems
Deflation Problem (1149); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon could not be fully deflated and got stuck in the scope.It was also noted that the balloon material bunched up.Another scope and cre fixed wire dilatation balloon were used to complete the procedure.There have been no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: problem code 1149 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 twisted.Additionally, it was noted that the catheter was mechanically cut near the balloon.The balloon portion of the device was not returned.Dimensional examination of the catheter was performed and was measured in three sections; distal, medium and proximal.The three sections were within specification.Functional analysis was unable to be performed due to the condition of the device.Based on the available information, it is possible that factors encountered during the procedure, the technique used by the physician during the procedure, and/or the interaction between the scope and the balloon could have caused the balloon damage.Therefore, the most probable root cause is adverse event related to procedure.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 during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon could not be fully deflated and got stuck in the scope.It was also noted that the balloon material bunched up.Another scope and cre fixed wire dilatation balloon were used to complete the procedure.There have been no patient complications reported as a result of this event.
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Search Alerts/Recalls
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