Catalog Number 1500300-15 |
Device Problems
Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/18/2019 |
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.(b)(4).The device is expected to be returned for investigation.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 the procedure was performed to treat a narrow and moderately calcified distal left anterior descending lesion.Pre-dilatation was done with an unspecified device.A 3.0x15mm rx xience sierra stent delivery catheter (sds) failed to cross due to the anatomy.Force was applied.Resistance was met with the anatomy during withdrawal and the distal shaft separated.The sds was simply withdrawn.A non-abbott stent was used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the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).Device code 2017-excessive force removed.Evaluation summary: the device was returned for analysis.The reported detachment of a device component (shaft separation) was confirmed.The reported failure to advance and difficulty to remove could not be replicated in a testing environment as it was based on circumstances of the procedure.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the narrow and moderately calcified lesion causing the reported failure to advance.Continued interaction with the anatomy during removal caused the reported difficulty to remove and subsequent detachment of a device component (shaft separation).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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