Catalog Number 1012269-08 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/09/2016 |
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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that during a procedure of the left anterior descending (lad) artery, the mini trek balloon dilatation catheter (bdc) was used at the lesion without issue.After removal from the anatomy it was noted that the balloon marker was at the distal tip of the balloon and not mid balloon.There was no reported adverse patient effect.A different balloon catheter and stent were used to complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Visual and dimensional inspections were performed on the returned device and the single balloon marker was noted to be within the allowed specification; therefore, the reported misaligned balloon marker was not confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.Based on the information reviewed, 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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