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Model Number CAT6KIT-A |
Device Problem
Material Deformation (2976)
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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 12/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the cat6 was kinked approximately 125.0, and 132.0 thru 135.0 cm from the hub.The cat6 was ovalized approximately 105.0, and 126.0 thru 128.0 cm from the hub.Conclusions: evaluation of the returned cat6 confirmed that the catheter was kinked.If the cat6 is forcefully advanced against resistance, damage such as a kink may occur.During the functional test, resistance was encountered while attempting to advance the returned cat6 through a demonstration peel able sheath due to the distal kink, and the cat6 could not be advanced any further.Further evaluation of the returned cat6 revealed ovalization along the catheter shaft.This damage was likely incidental to the reported complaint.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.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 superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, the physician removed the cat6 midway through the procedure to flush.Afterwards, while attempting to reinsert the cat6 into the sheath without the use of a guidewire, the physician kinked the cat6.Therefore, the cat6 was removed.The procedure was completed using a new cat6, a guidewire, and the same sheath.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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