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Model Number A22026A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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E1.Full establishment name: (b)(6).The device was returned, and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the outer sheath, 26 fr., 2 stopcocks, rotatable had the lock part come loose during the procedure.There were no reports of patient harm.
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Manufacturer Narrative
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This supplemental report is to provide a correction to the initial medwatch report (mdr).This supplemental report is to inform that upon further review this is not a reportable malfunction.The initial report was reported out of caution as the reportable malfunction occurred during a procedure.However, clinical assessment has determined that this event does not meet serious injury reporting criteria per the fda definition in title 21 cfr part 803.Additionally, the iuc is non-pae and the final fuc codes are non-pae.Per the legal manufacture, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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