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Model Number CATRXKIT |
Device Problems
Positioning Problem (3009); Physical Resistance/Sticking (4012)
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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 01/17/2021 |
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.
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Event Description
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The patient was undergoing a thrombectomy procedure in the circumflex using an indigo system catrx aspiration catheter (catrx) and a guidewire.During the procedure, the physician encountered resistance while advancing the catrx and reported that the catrx would not cross the lesion.Therefore, the catrx was removed.No physical damage was reported.The procedure was completed using a non-penumbra catheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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