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Model Number M00542253 |
Device Problem
Failure to Fire (2610)
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Patient Problems
Hemorrhage/Bleeding (1888); Laceration(s) (1946); No Code Available (3191)
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Event Date 01/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device code (b)(4) for the reportable issue of bands failed to deploy.Patient code (b)(4) captures the reportable event of patient bleeding requiring additional intervention and patient intubation.Patient code (b)(4) captures the reportable event of laceration.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) with variceal banding procedure performed on (b)(6) 2020.During the procedure, the speedband device was used in an attempt to stop the bleeding of the esophageal varices.The first two bands successfully deployed, and another two bands were attempted to be deployed, but the bands failed to deploy and blocked the ligator cap visualization.The scope was removed from the patient.A second speedband device was used; however, the same issue occurred.The physician then used a hemospray to stop the bleed.A pediatric esophagogastroduodenoscopy (egd) scope was also used to remove the blood.The patient was then intubated and was brought to the intensive care unit (icu).The physician assessed that the "bands lacerated the varices during the procure." the patient has since been discharged from the icu, however the exact discharge date was not reported.The patient's current condition was reported to be stable.
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Manufacturer Narrative
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Patient's weight - (b)(6).Device code (b)(4) for the reportable issue of bands failed to deploy.Patient code (b)(4) captures the reportable event of patient bleeding requiring additional intervention and patient intubation.Patient code (b)(4) captures the reportable event of laceration.Conclusion code (b)(4) is being used in lieu of an adequate conclusion code for device not returned.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) with variceal banding procedure performed on (b)(6) 2020.During the procedure, the speedband device was used in an attempt to stop the bleeding of the esophageal varices.The first two bands successfully deployed, and another two bands were attempted to be deployed, but the bands failed to deploy and blocked the ligator cap visualization.The scope was removed from the patient.A second speedband device was used; however, the same issue occurred.The physician then used a hemospray to stop the bleed.A pediatric esophagogastroduodenoscopy (egd) scope was also used to remove the blood.The patient was then intubated and was brought to the intensive care unit (icu).The physician assessed that the "bands lacerated the varices during the procure." the patient has since been discharged from the icu, however the exact discharge date was not reported.The patient's current condition was reported to be stable.
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Search Alerts/Recalls
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