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Model Number M00558440 |
Device Problems
Difficult to Advance (2920); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Weight: (b)(6).(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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Note: this report pertains to one of two cre wireguided dilation balloons used during the same procedure and same patient.It was reported to boston scientific corporation that two cre wireguided dilation balloons were used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was introduced into the scope and the physician was unable to pass through the end.The scope was then removed and a new balloon was used, but the new balloon had the same issue.The patient had already been sedated by this point, but the procedure was not completed due to this event.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block a3: weight: 81.63 kg block h6: device code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation result visual examination of the returned complaint device found the balloon had no damages.The catheter of the device was inspected and it was found that it had two kinks.Dimensional examination of the catheter was performed and was measured in three sections; distal, medium and proximal.Based on the most relevant information of the complaint event description, device analysis, and the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections.This failure is likely due to factors encountered during the procedure, such as handling of the device, the technique used by the physician, the interaction with the scope, and normal procedural difficulties encountered during the procedure, that could have affected device performance and its intended purpose.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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Note: this report pertains to one of two cre wireguided dilation balloons used during the same procedure and same patient.It was reported to boston scientific corporation that two cre wireguided dilation balloons were used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6).2020.According to the complainant, during the procedure, the balloon was introduced into the scope and the physician was unable to pass through the end.The scope was then removed and a new balloon was used, but the new balloon had the same issue.The patient had already been sedated by this point, but the procedure was not completed due to this event.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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