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Model Number CATRXKIT |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
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.This report is associated with mfr report number: 3005168196-2021-02422.
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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) and aspirating tubing (tubing).During the procedure, the physician was unable to attach the tubing onto the back of the catrx.Therefore, the catrx was removed.The procedure was completed using a new tubing and catrx.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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