Catalog Number CDS0702-XTW |
Device Problems
Mechanical Jam (2983); Physical Resistance/Sticking (4012)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/26/2023 |
Event Type
Injury
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Event Description
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This is filed to report an inability to remove the gripper line and foreign body.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.An xtw clip was inserted and placed on the mitral valve.However, during deployment the gripper lines were unable to be removed from the clip.Troubleshooting was performed, and one of the gripper lines was able to be removed.The other gripper line remained attached to the clip, therefore, the line was cut at the groin and remained in the patient.No additional treatment was performed.Mr reduced to a grade of 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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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.
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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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, the cause of the reported unable to remove gripper line and difficult gripper line removal were unbale to be removed.The reported foreign body in patient was a cascading event of the reported unable to remove gripper line.The reported unexpected medical intervention was a result of case-specific circumstances.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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