Model Number H7493926712400 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that a shaft break occurred.A 4.00mm x 12mm nc emerge balloon catheter was selected for dilation.However, when the balloon was about to insert, the shaft broke in half approximately 80cm from the hub.The device was not used inside the patient.The procedure was completed with another 4.00mm x 12mm emerge balloon catheter.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.There was contrast and blood in the inflation lumen.The balloon was loosely folded.The shaft and hypotube were examined.There were numerous hypotube kinks.The hypotube was fractured 76cm from the hub.The fracture faces were oval as if kinked prior to separation.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
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Event Description
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It was reported that a shaft break occurred.A 4.00mm x 12mm nc emerge® balloon catheter was selected for dilation.However, when the balloon was about to insert, the shaft broke in half approximately 80cm from the hub.The device was not used inside the patient.The procedure was completed with another 4.00mm x 12mm emerge balloon catheter.No patient complications were reported.
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Search Alerts/Recalls
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