Catalog Number 1070250-18 |
Device Problems
Detachment Of Device Component (1104); Difficult To Position (1467)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/23/2015 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a moderately tortuous and moderately calcified proximal diagonal artery.Pre-dilatation was performed with a 2.5 x 15 mm trek balloon catheter.A 2.5 x 18 mm xience xpedition stent delivery system was being inserted through the guiding catheter when there was resistance and the proximal shaft, outside the anatomy, separated.The device was easily removed.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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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 evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.The reported shaft detachment was able to be confirmed.The reported difficulty to position was unable to be replicated in a testing environment due to the condition of the returned device.Based on a visual inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.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 did not indicate a lot specific quality issue.Based on the information reviewed, there is no evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling.
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Manufacturer Narrative
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(b)(4).Added dimensional testing to analysis.Evaluation summary: the device was returned for analysis.The reported shaft detachment was able to be confirmed.The reported difficulty to position was unable to be replicated in a testing environment due to the condition of the returned device.Based on a visual and dimensional inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.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 did not indicate a lot specific quality issue.Based on the information reviewed, there is no evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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