Catalog Number CDS0201 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Event Description
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This report is being filed as a leak was noted in the clip delivery system (cds) during preparation.Although there was no patient involvement, if this were to recur in the anatomy, a leak has potential of air embolism.It was reported that during device preparation, while flushing the clip delivery system (cds), a leak was noted below the lock lever cap, above the thread.The cap was tightened and the leak continued.The device was unlocked and re-tightened, however the leak continued.The device was not used and there was no patient involvement.There was no additional information provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the returned device analysis confirmed the leak at the lock lever.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the reported cds leak could not be determined.It is possible that the user technique during device preparation contributed to the reported leak; however, this cannot be confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Search Alerts/Recalls
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