Catalog Number 1012451-08 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the 3.5 x 8 mm nc trek balloon catheter was prepped for use and prior to loading onto the guide wire it was noted that the plastic luer connector [hub] came off.There was no patient involvement.There was no clinically significant delay in the procedure.Another device was used in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was returned for analysis and abbott vascular (av) confirmed the reported separation at the hub.Av reviewed the lot history record and there were no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other incidents reported from this lot.Av conducted root cause analysis and determined the issue may be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.
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Search Alerts/Recalls
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