Model Number H7493926012250 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
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Event Description
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It was reported that the product was mislabeled.A 2.50x12mm synergy ii drug-eluting stent was deployed in a coronary artery and the procedure was completed successfully.No patient complications were reported.After the procedure the physician scanned a smaller bar code which on the package inside the device box and the scan indicated the device was a 3.5x16 maverick balloon catheter but when a larger bar code on the package was scanned, the scan indicated the correct device (2.50x12mm synergy ii).
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Search Alerts/Recalls
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