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Model Number M00513840 |
Device Problems
Failure to Advance (2524); Material Twisted/Bent (2981); Positioning Problem (3009); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be file.
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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 # 3005099803-2021-06336 and 3005099803-2021-06337 for the associated device information.It was reported to boston scientific corporation on november 15,2021 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a 12 cm malignant esophageal stenosis during a gastroscopy procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, there was difficulty advancing the delivery system of a 15cm ultraflex esophageal stent (the subject of mfr.Report # 3005099803-2021-06336) through the stricture.The distal part of the delivery system was bent the stent was deployed in an incorrect location.It was observed under direct visualization with a pediatric gastroscope that the stent did not fully expand.The stent was removed from the patient using a re-usable grasping forceps.A 10 cm ultraflex esophageal stent (subject of this report) was attempted to be deployed, but similar problems occurred; the delivery system had difficulty advancing through the stricture, the distal part of the delivery system was bent, the stent was deployed in an incorrect location and the stent did not fully expand.The 10 cm ultraflex esophageal stent was removed from the patient using re-usable grasping forceps and the procedure was cancelled and rescheduled due to device availability.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Blocks b1, b2 (outcomes attribute to adverse event), b5, e1 (initial reporter's first name), h1 and h6 (impact codes) have been updated with additional information received on (b)(6), 2021.Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Medical device problem code a150101 captures the reportable event of stent failure to expand.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be file.Block h11: block g2 (report source) has been corrected.
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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 # 3005099803-2021-06336 and 3005099803-2021-06337 for the associated device information.It was reported to boston scientific corporation on (b)(6),2021 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a 12 cm malignant esophageal stenosis during a gastroscopy procedure performed on (b)(6), 2021.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, there was difficulty advancing the delivery system of a 15cm ultraflex esophageal stent (the subject of mfr.Report # 3005099803-2021-06336) through the stricture.The distal part of the delivery system was bent the stent was deployed in an incorrect location.It was observed under direct visualization with a pediatric gastroscope that the stent did not fully expand.The stent was removed from the patient using a re-usable grasping forceps.A 10 cm ultraflex esophageal stent (subject of this report) was attempted to be deployed, but similar problems occurred; the delivery system had difficulty advancing through the stricture, the distal part of the delivery system was bent, the stent was deployed in an incorrect location and the stent did not fully expand.The 10 cm ultraflex esophageal stent was removed from the patient using re-usable grasping forceps and the procedure was cancelled and rescheduled due to device availability.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2021*** it is unknown if the 10cm ultraflex esophageal stent was removed from the patient.
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Search Alerts/Recalls
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