Catalog Number PSR3D |
Device Problems
Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the penumbra system 3d revascularization device (psr3d) was kinked approximately 173.5 cm from the proximal end of the wire.The psr3d was intact with its delivery wire.Conclusions: evaluation of the returned device revealed that the psr3d was kinked.This type of damage typically occurs due to improper handling during removal from the packaging.If the device is forcefully retracted out of its packaging hoop at extreme angles, damage such as this may occur.Penumbra psr3ds 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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During preparation for a thrombectomy procedure, the hospital staff noticed that a penumbra system 3d revascularization device (psr3d) was bent upon removal from the packaging.The damaged psr3d was found prior to use and therefore, was not use for the procedure.The procedure was completed using a new psr3d.
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Manufacturer Narrative
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Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.1.Section h.Box 6.Results code 1 h3 other text : placeholder.
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Search Alerts/Recalls
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