Catalog Number 1120300-18 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/25/2018 |
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 customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that before use, the shaft of a 3.0 x 18 mm xience alpine stent delivery system (sds) was noted to be kinked.Additionally, the package was noted to be faulty.There was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was not returned for analysis.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported kink and packaging tears, rips, holes (faulty packaging).There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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