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Model Number M00558840 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device code (b)(4) relates to problem code for the reported event of exit marker bunched up.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 pro gi wireguided dilatation balloon was used in the esophagus during a gastrointestinal dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while removing the device from the scope, the black exit marker bunched up and the device got stuck inside the endoscope.Reportedly, the endoscope and the device were removed from the patient and the catheter was cut to remove the device from the endoscope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Investigation results: visual examination of the returned complaint device confirmed that the black exit marker was bunch-up.It was also noted that the catheter was cut near the balloon hub.Functional analysis could not be performed due to the condition of the device.Based on the condition of the returned device, the noted defects likely occurred due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
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Event Description
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It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the esophagus during a gastrointestinal dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while removing the device from the scope, the black exit marker bunched up and the device got stuck inside the endoscope.Reportedly, the endoscope and the device were removed from the patient and the catheter was cut to remove the device from the endoscope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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