Catalog Number 11005-39 |
Device Problems
Difficult to Remove (1528); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 to treat a right common iliac artery.A 9x39mm omnilink elite stent was attempted to be advanced via a 6f sheath but became stuck within the sheath.The device and sheath were removed altogether.The sheath was upsized to 7f and another same size omnilink elite was 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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A visual inspection was performed on the returned device.The reported difficult to advance and difficult to remove could not be tested due to condition of the returned device.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.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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Search Alerts/Recalls
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