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Catalog Number CATRXKIT |
Device Problem
Material Puncture/Hole (1504)
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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 10/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
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Event Description
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The patient was undergoing a thrombectomy procedure in the right coronary artery (rca) using an indigo system catrx aspiration catheter (catrx).During the procedure, while attempting to load the catrx onto the guidewire, the proximal end of the guidewire punctured through the catrx prior to exiting the rapid exchange lumen.Therefore, the catrx was removed.The procedure was completed using a new catrx.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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