Catalog Number CAT8XTORQ115 |
Device Problems
Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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During preparation for a medical procedure, the hospital staff found that the indigo system aspiration catheter 8 (cat8) had been crushed at the middle of the catheter, before removal from the packaging.The damage to the cat8 was found prior to use and therefore it was not used in the procedure.The procedure was completed using another cat8.
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Manufacturer Narrative
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Results: the cat8 was ovalized from approximately 48.0 ¿ 49.0 cm from the hub.Conclusions: evaluation of the returned cat8 confirmed an ovalized device.The reported complaint mentioned that the damage occurred before removal of the device from its packaging.This damage was likely a result of improper handling during transit or during storage of the device.The root cause of the reported complaint could not be determined.Penumbra catheters are 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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Search Alerts/Recalls
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