Catalog Number 1012451-15 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/14/2017 |
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 procedure was performed to treat a lesion in the left anterior descending (lad) artery.When the 3.5 x 15 mm nc trek balloon dilatation catheter (bdc) began to be inserted into the rotating hemostatis valve (rhv), the shaft broke.There was an additional kink in the shaft.The device was not used and was replaced with a non-abbott bdc.There was no adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported proximal shaft separation and kink were 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 incidents from this lot.The investigation determined the reported shaft separation and kink appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
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Search Alerts/Recalls
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