Model Number SGC0701 |
Device Problems
Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2022 |
Event Type
malfunction
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Event Description
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This being filed to report the hemostatic valve break.It was reported that during preparation of the steerable guide catheter (sgc), a three-way stopcock was attached to the hemostatic valve and when a syringe was attached to the stopcock, the valve and stopcock broke away from device.The device was not used.There was no clinically significant delay in the procedure and no patient involvement.Subsequent to the initially reported information, the device analysis found that the hemostasis valve broke.No additional information was provided.
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Manufacturer Narrative
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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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Subsequent to the initially reported information.The device analysis found that the hemostasis valve broke.
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Manufacturer Narrative
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A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.A review of lot-specific similar complaints identified no other complaints reported from this lot.The returned device analysis confirmed the reported separated steerable guide catheter (sgc) flush port.Based on available information and the returned device analysis, a cause for the separated sgc flush port could not be determined.It is possible that user technique during device preparation contributed to this issue.However, this cannot be confirmed.The reported incorrect procedure or method is due to the user not using high pressure tubing to connect the syringe and flush port.It should be noted that the mitraclip g4 system instructions for use (ifu) states ¿connect high pressure tubing and a 50-60 cc syringe filled with heparinized saline to the guide flush port.¿ in this case, it was reported that the user did not use tubing to connect the stopcock and the syringe.However, it cannot be confirmed if this contributed to the separated flush port.There is no indication of product issue with respect to manufacture, design or labeling.H6: medical device problem code 2017 (improper or incorrect procedure or method).H6: medical device problem code added.
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Search Alerts/Recalls
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