Catalog Number 1550350-38 |
Device Problems
Loose or Intermittent Connection (1371); Contamination /Decontamination Problem (2895)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/30/2019 |
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 was received.The investigation is not yet complete.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 the procedure was to treat the circumflex artery that did not have tortuosity or calcification.A 3.5 x 38 mm xience sierra stent delivery system (sds) was used.The device was loaded onto an unspecified guide wire that was inside the anatomy, and an inflation device was used.However, it was noted that there was foreign material on the hub of the sds.The foreign material stayed on the device and did not separate into two separate pieces.Due to this foreign material, the sds could not connect with the inflation device.Another 3.5 x 38 mm xience sierra sds was then used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Internal file number: (b)(4).Evaluation summary: the device was returned for analysis.The reported foreign material present on device was not confirmed.The reported loose or intermittent connection was confirmed.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 similar incidents from this lot.Although the investigation was unable to confirm the reported foreign material on the hub it is likely the noted flash was identified as foreign material.Therefore, the investigation determined the noted flash appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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Search Alerts/Recalls
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