Catalog Number SGC0302 |
Device Problems
Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/19/2019 |
Event Type
Injury
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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.(b)(4).The customer reported the clip was discarded.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 is filed to report a leak in the steerable guide catheter.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.After the transseptal puncture was achieved, the dilator was retracted into the steerable guide catheter (sgc).After the dilator was retracted halfway into the sgc, the physician recognized a completely aired hemostatic chamber of the sgc.Two 50-60cc syringes of air and blood mixture were aspirated until the blood column in the chamber increased.While aspirating, the physician made sure that the three-way stopcock was closed.The procedure was continued and there were no issues with air in the devices or anatomy.It was noted that the hemostatic valve was kept closed.One clip was implanted reducing mr to a grade 1.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Device codes: 2017 labeled.Internal file number - (b)(4).Correction: device code 2017 (failure to follow steps/instructions) added.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported for leaks from this lot.It should be noted that as per the mitraclip instructions of use states: loosen the lock lever and gripper lever caps to de-air.Do not turn lever caps more than half a turn in the open direction.All available information was investigated and the reported leak appears to be due to the user technique/error of turning the lever caps more than half a turn in the open direction during the device preparation.Additionally, the improper or incorrect procedure appears to due to the user error/failure to follow steps as the user turned the lock lever more than half to de-air the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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