Catalog Number 1074275-28 |
Device Problems
Leak/Splash (1354); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/21/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.The reported inflation difficulties and torn material were able to be confirmed.Based on a visual and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the electronic complaint database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.
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Event Description
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Using a radial artery access approach during an unspecified coronary artery procedure the 2.75 x 28 mm xience xpedition stent delivery system (sds) was inflated but a hole in the orange part of the shaft prevented the balloon inflation.It was noted that the stent was deployed.There were no adverse patient effects and no clinically significant delay reported.No additional information was provided.
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Manufacturer Narrative
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(b)(4).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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Search Alerts/Recalls
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