Catalog Number 1012448-12 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2018 |
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.Estimated.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 nc trek had a "faulty hub" during patient use.There were no reported adverse patient effects nor any clinically significant delay reported.No additional information was reported.The device returned to abbott vascular with the following observed: the device did not show signs of use although contrast was on the shaft.The device returned with a hypotube separation at the distal end of the strain relief.
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Manufacturer Narrative
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(b)(4).Evaluation summary: a visual inspection was performed and the reported faulty hub was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported difficulties and subsequent damages appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling/manipulation was applied to the device during preparation resulting in the hypotube separation, the appearance of a faulty hub and damage to the strain relief as the separation was located on the hypotube and distal end of the hub/strain relief.The fractured faces of the separated hypotube were ovalled as if kinked prior to separation.The noted bends on the hypotube likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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