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 01/30/2018 |
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.
Date of event estimated.
The device is expected to be returned for evaluation.
It has not yet been received.
A follow-up will be submitted with all relevant information.
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Event Description
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It was reported that the nc trek broke when loading over the guide wire.
There was no part of the separation inside the patient anatomy.
There was no retrieval of the separation necessary.
Another device was used to complete the procedure.
No additional information was provided.
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Manufacturer Narrative
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(b)(4).
Date of event was confirmed to be (b)(6) 2018.
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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Event Description
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The following additional information was received: there was no adverse patient effect and no reported clinically significant delay in the procedure.
No additional information was provided.
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Search Alerts/Recalls
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