Model Number CAT6KIT-A |
Device Problems
Material Deformation (2976); 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 11/27/2020 |
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 medical procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, while advancing the cat6 into the sheath, the physician experienced resistance and kinked the cat6 approximately three centimeters from the distal tip.Therefore, the cat6 was removed.The procedure was completed using a new cat6.There was no report of an adverse effect to the patient.
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Event Description
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The patient was undergoing a medical procedure using an indigo system aspiration catheter 6 (cat6) and non-penumbra sheath.During the procedure, while advancing the cat6 into the sheath, the physician experienced resistance and the cat6 became kinked approximately three centimeters from the distal tip.Therefore, the cat6 was removed.The procedure was completed using a new cat6 and the same sheath.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/15/2021: 1.Section b.Describe event or problem.H3 other text : placeholder.
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Search Alerts/Recalls
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