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Model Number 140806 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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Event Description
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As reported, during use in patient of this fogarty corkscrew catheter, the latex covering the filaments was ripped.There was no allegation of patient injury.The device was available for evaluation.
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Manufacturer Narrative
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One fogarty catheter was received for evaluation.The report of "latex covering the filaments was ripped" was unable to be confirmed.There was no visible damage observed in the core wire, catheter body, latex membrane and the spring body.It was possible to move the thumb slide on the handle forwards and backwards and the membrane extended and contracted respectively without difficulty.Since no faults was identified in the evaluation of the actual device, alleged physical malfunction was not confirmed.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.
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Search Alerts/Recalls
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