Catalog Number 1012451-20 |
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 02/07/2018 |
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 procedure was to treat a moderately calcified lesion located in the left anterior descending artery.
When advancing a 3.
50 x 20 mm nc trek balloon catheter over an unspecified guide wire, the shaft separated into two pieces outside the anatomy.
Another 3.
5 x 20 mm nc trek was used to successfully complete the procedure.
There was no clinically significant delay in the procedure and no adverse patient effects.
No additional information was provided.
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Manufacturer Narrative
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(b)(4).
Visual inspection was performed on the returned device.
The reported separation was 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 difficulty appears to be related to operational context.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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