Model Number BMK6F95MBER120 |
Device Problems
Collapse (1099); Device Damaged Prior to Use (2284); Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.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 thrombectomy procedure using a benchmark delivery microcatheter (benchmark), the physician found that the tip of the benchmark was kinked and flattened.The damage to the benchmark was found prior to use and therefore, it was not used in the procedure.The procedure was completed using another benchmark.
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Manufacturer Narrative
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Results: the benchmark delivery microcatheter (benchmark) was kinked approximately 6.0, 42.0, 77.5 and 79.5 cm from the hub.The device was ovalized from approximately 95.0 ¿ 96.5 cm from the hub.The device was fractured approximately 96.5 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a distal ovalization and revealed a fractured distal tip.If the packaging mandrel becomes unsecured from the packaging card, it may pin the benchmark between the packaging tube and packaging mandrel during retraction from the packaging.If the benchmark is subsequently retracted while its distal tip is pinned, the distal tip will likely become damaged.Further evaluation revealed kinks throughout the device.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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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Manufacturer Narrative
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Please note that the following section was incorrectly reported on the follow-up #01 mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2019-00937.1.Section h.Box 10/11.Narrative/corrected data results: the benchmark was kinked approximately 6.0, 42.0, 77.5 and 79.5 cm from the hub.The device was ovalized from approximately 95.0 ¿ 96.5 cm from the hub.The device was fractured approximately 96.5 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed the ovalization and revealed the tip was fractured.The tip of the device is packaged with a mandrel within the tip of the device that would prevent this damage prior to removal from its packaging.If the tip of the device becomes pinched or gripped inadvertently during of after removal from the packaging, the tip will likely become ovalized.If the tip is further manipulated it may eventually fracture.Further evaluation revealed kinks throughout the device.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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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