Model Number H74938046830750 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.The sheath used during the procedure was not returned for analysis.A stringy clear material was noted to be attached to the stent on the express ld device.The express ld device was returned with the stent fully mounted onto the delivery device.The balloon was tightly folded and the stent was in the correct position on the balloon material.No damage or any issues were noted on the returned delivery device that could have contributed to the complaint incident.The stent was returned fully mounted onto the delivery system.A visual and microscopic examination identified a clear stringy foreign material intertwined around some stent struts approximately 4mm distal to the distal edge of the proximal markerband.The clear stringy foreign material was noted to be approximately 240mm in length.No issues were noted with the returned stent that could have contributed to the complaint incident.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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Event Description
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It was reported that a foreign matter was found stuck on the stent.The target lesion was located in the superior mesenteric artery.An 8.0x30x75cm express® ld iliac / biliary stent was selected for use to treat the lesion.However, it was noted that there was a string hanging off of the stent.The procedure was completed using a different device.No patient complications were reported.
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Search Alerts/Recalls
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