Catalog Number CDS0702-NTW |
Device Problems
Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.H6: device code 2017 - failure to follow steps / instructions.
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Event Description
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It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+.When inserting the ntw lot; 30724r1044 clip delivery system, insertion was difficult as it not performed co-axially resulting in the hemostasis valve breaking.Air entered the steerable guide catheter requiring aspiration to avoid air entering the patient.A replacement sgc was used to implant ntw lot; 30724r1044 and nt lot: 30609r1039nt successfully, reducing mr to grade 1.There was no clinically significant delay.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and based on the information provided, the reported difficult cds insertion resulting in tearing the silicone valve of the sgc hemostasis valve (device causing damage) appears to be related to user technique of cds insertion.There is no indication of a product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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