Model Number 1012452-15 |
Device Problems
Material Separation (1562); Failure to Advance (2524)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 01/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.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 preparation, before advancing the 3.75x15mm nc trek balloon dilatation catheter (bdc) into the copilot, the shaft separated near the balloon.The device was not used.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
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Event Description
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Subsequent to the initially filed medwatch report, additional information was received.While using this coronary dilatation balloon, some resistance was met in the stenosis.While trying to pass through the coronary lesion, the shaft of the dilatation catheter snapped.The balloon was removed from the body and a new device was then opened and proceeded with the case.No additional information was provided.
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Manufacturer Narrative
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Visual and dimensional inspections were performed on the returned device.The reported separation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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 and/or complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.H6: patient code 2645 removed.
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Search Alerts/Recalls
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