Model Number EP003994S |
Device Problems
Break (1069); Material Fragmentation (1261); Activation, Positioning or Separation Problem (2906); Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 990061-070.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during insertion of the needle into the sheath, the trans- septal needle scratched inside the dilator of the sheath and debris was observed on a compress.The needle and sheath were replaced with resolve.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the needle, ep003994s with lot number 215155804.Visual inspection of the needle showed no physical damage.The outer diameter of the needle was within specification.In conclusion, evidence of skiving was observed, however the device was found to meet manufacturing requirements.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the transseptal needle, (b)(4) with lot number 215155804, was returned and analyzed.No physical damaged can be identified through the visual inspection on the needle.The outer diameter of the needle was within the specification.However, it is plausible that skiving occurred as there is a compatibility issue with the needle and a competitor sheath.The cause of the issue was not established.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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