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Model Number CATRXKIT |
Device Problem
Suction Failure (4039)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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The patient was undergoing a thrombectomy procedure in the left anterior descending artery (lad) using an indigo system catrx aspiration catheter (catrx) and a non-penumbra guide catheter.During the procedure, it was reported that the catrx would not aspirate.Therefore, the catrx was removed.The procedure was completed using a non-penumbra catheter with a balloon stent device and the same guide catheter.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Evaluation of the returned catrx revealed blood clotted within the lumen.Once the clot was flushed from the returned device with the help of a stainless-steel mandrel, the device was able to aspirate without issue.The inability to flush the clot from the lumen of the device during the procedure could not be determined.Further evaluation of the catrx revealed bends and kinks throughout its length, the guidewire lumen was damaged on its proximal end and punctured near the distal tip.This damage was likely incidental to the reported complaint.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
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Search Alerts/Recalls
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