Model Number 20300 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2021 |
Event Type
malfunction
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Event Description
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It was reported that foreign material was noted on the device.During preparation of a 10x100x120 epic stent, the physician noted a glue-like material in the delivery system.The procedure was completed with a different device.No patient complications were reported.
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Event Description
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It was reported that foreign material was noted on the device.During preparation of a 10x100x120 epic stent, the physician noted a glue-like material in the delivery system.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the pouch is bent in half.The device was taken out of the pouch to be inspected.The sheath is kinked 85cm from the tip.The sheath is damaged 17cm from the tip.The sheath is pulled out of the nosecone.Microscopic examination revealed no additional damages.The rack is inside the handle and the lock is missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the device appears to have been used and damaged which would contribute to the reported glue-like substance seen on the device.
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Manufacturer Narrative
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(d4) lot number: updated to 0026258299.(d4) expiration date: updated to 10/27/2023.(d4) unique identifier (udi) #: updated to (b)(4).(g1) mfr site facility name: updated from boston scientific ireland limited to boston scientific corporation (g1) mfr site address 1: updated to ballybrit business park (h4) device manufacture date: 10/27/2020 device evaluated by mfr: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the pouch is bent in half.The device was taken out of the pouch to be inspected.The sheath is kinked 85cm from the tip.The sheath is damaged 17cm from the tip.The sheath is pulled out of the nosecone.Microscopic examination revealed no additional damages.The rack is inside the handle and the lock is missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the device appears to have been used and damaged which would contribute to the reported glue-like substance seen on the device.
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Event Description
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It was reported that foreign material was noted on the device.During preparation of a 10x100x120 epic stent, the physician noted a glue-like material in the delivery system.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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