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Model Number M00513850 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/04/2015 |
Event Type
malfunction
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2015-01788 and 3005099803-2015-01789 for the associated device information.It was reported to boston scientific corporation that two ultraflex¿ esophageal ng stents were used to treat a malignant stricture in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2015.According to the complainant, during the procedure the physician noted that the first ultraflex¿ esophageal ng stent (the subject of mfr report # 3005099803-2015-01788) would not cross the stenosis.The stent was removed without any issues and the physician dilated the stenosis with a cre balloon.After dilation a second attempt was made to cross the stenosis with the same ultraflex¿ esophageal ng stent, but was unsuccessful.During the second attempt, the physician noted that the dilation tip was bent.The device was removed again without any problems.An attempt was then made to use a shorter ultraflex stent (the subject of mfr report #3005099803-2015-01789), but the dilation tip also bent trying to cross through the stenosis.The device was removed without any issues.The physician chose to not attempt to place another stent at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and the patient was prescribed to receive medical palliative treatment.
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Manufacturer Narrative
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Exact patient age is unknown; however, the patient was reported to be over 18 years old.Reported event of tip bent.The device has been received for analysis; however, 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 medwatch will be filed.
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Manufacturer Narrative
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A ultraflex¿ esophageal ng stent was returned for analysis; the stent was fully crocheted onto the returned device.No issues were noted with the profile of the crocheted section of the device.A bend was noted on the shaft proximal to where the stent was positioned.No issues were noted with profile of the tip.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2015-01788 and 3005099803-2015-01789 for the associated device information.It was reported to boston scientific corporation that two ultraflex esophageal ng stents were used to treat a malignant stricture in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2015.According to the complainant, during the procedure the physician noted that the first ultraflex esophageal ng stent (the subject of mfr report # 3005099803-2015-01788) would not cross the stenosis.The stent was removed without any issues and the physician dilated the stenosis with a cre balloon.After dilation a second attempt was made to cross the stenosis with the same ultraflex esophageal ng stent, but was unsuccessful.During the second attempt, the physician noted that the dilation tip was bent.The device was removed again without any problems.An attempt was then made to use a shorter ultraflex stent (the subject of mfr report #3005099803-2015-01789), but the dilation tip also bent trying to cross through the stenosis.The device was removed without any issues.The physician chose to not attempt to place another stent at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and the patient was prescribed to receive medical palliative treatment.
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Search Alerts/Recalls
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