Model Number H802227680040 |
Device Problems
Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that the package seal and sterility was compromised.A 1.75mm rotalink burr wa selected for use during a rotational atherectomy procedure with diffuse calcification.When they were getting the device ready for the case, they noticed that the packaging was opened and therefore not sterile.They completed the procedure with another with same device.No patient complications reported.
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Search Alerts/Recalls
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