Device history record review: a device history records (dhr) review was performed for the promus premier select referenced batch (0031891839).The manufacturing review confirmed that all devices associated with this batch were the correct size (16 mm x 2.75 mm) per manufacturing records and box labelling.The promus premier select 16 mm x 2.75 mm has a minimum stent length specification of 15.71 mm, and a maximum stent length specification of 17.21 mm.Any stent length that falls outside of these limits is automatically scrapped.All distributed devices from finished goods batch (fgb) 0031891839 passed this inspection and were within the specified stent length limits.From the thorough investigation of all data gathered, it is not possible for a fgb of 16 mm x 2.75 mm devices to include a 20 mm x 4.00 mm sized device.Device analysis: the promus premier select device was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Printed on the manifold number was the stent size of a 4.00 x 20mm stent, however the actual device measured correctly per the box labelling, which was labelled as a 16mm x 2.75 promus premier select.No other device issues were noted during analysis.Labeling review: based on the available information, there was no evidence of device misuse, off-label use, or failure to follow the promus premier select coronary stent system instructions for use (ifu).Investigation conclusion: based on a thorough review of the reported event, boston scientific has assigned an investigation conclusion code of 'manufacturing deficiency', since the problem was traced to the manufacturing process.The print size on the hub was a 4.00 x 20mm, however the actual device measured correctly per the box labelling, which was labelled as a 16mm x 2.75 promus premier select.An ncep investigation has been initiated to identify the cause of the incorrect product size etched on the hub manifolds from this batch (0031891839).In addition, boston scientific initiated a medical device removal (97172244-fa) of batch 0031891839 of promus premier select coronary stent systems on 11 march 2024 due to an incorrect product size printed on the catheter manifold hub.
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