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Model Number CATRXKIT |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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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 09/18/2020 |
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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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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, the physician inserted the catrx into the target vessel and upon getting ready for aspiration, the physician noticed the catrx was not fully aspirating.The catrx was then removed and the physician placed the tip of the catrx into a bowl of saline to test it; however, the catrx was unable to fully aspirate.Therefore, it was not used for the remainder of the procedure.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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