Catalog Number SGC0101 |
Device Problems
Kinked (1339); Improper or Incorrect Procedure or Method (2017); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/13/2016 |
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.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The mitraclip clip delivery system referenced is filed under a separate manufacturing report number.
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Event Description
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This report is filed for the tear noted on the soft tip of the steerable guide catheter.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy.This was a mitraclip procedure performed on (b)(6) 2016 to treat degenerative mitral regurgitation (mr) with a grade of 4 via direct right atrial access, mini-thoracotomy.The patient anatomy was challenging.The steerable guiding catheter (sgc) was advanced into the right atrium; it was noted on fluoroscopy that the distal portion of the sgc was kinked.During retraction of the clip delivery system (cds) into the sgc, the clip got caught on the steerable guide tip.Standard trouble shooting was performed to remove the cds from the tip of the sgc and a tear was noted on the sgc tip.The sgc was replaced with another sgc.The same cds was advanced to the mitral valve, steering was challenging due to the patient's rotated heart and the clip got caught in the chordae.Standard troubleshooting was performed to free the cds and the clip was successfully deployed in a1/p1 leaflet segment.At the end of the procedure mr remained unchanged at grade 4 with the one clip implanted.The patient is stable.There were no adverse patient effects and no clinically significant delay in the procedure.The patient will have a consult for possible mitral valve surgical repair or replacement.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual inspection and functional testing were performed on the returned device.The reported steerable guide catheter (sgc) torn soft tip and kink in the guide shaft were confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported clip getting caught on the guide tip, resulting in the identified tears in the soft tip appears to be a procedural condition of the kinked guide.Furthermore, challenging patient anatomy likely contributed to the kink observed in the guide after the sgc was inserted into the anatomy.It should be noted that the mitraclip instructions indicates that the left atrium should be accessed using transvenous, transseptal techniques.The challenging patient anatomy appears to have necessitated the right atrial access mini-thoracotomy.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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