Catalog Number 1070300-15 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2016 |
Event Type
malfunction
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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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Event Description
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It was reported that during unpacking of a 3.0 x 15 mm xience xpedition stent delivery system, the (b)(6) pouch was found already opened.The chipboard box did not appear to have been opened and the foil pouch was still sealed.The device was not used.Another stent delivery system was successfully used to complete the procedure.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).Evaluation summary: the device was returned for analysis.Visual inspections were performed on the returned device.The opened packaging seal was confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.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 identified no other similar incidents from this lot.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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