Catalog Number SGC01ST |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/31/2016 |
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.The third cds (lot 51009u233) was advanced; however, during use with m-knob, the clip moved in the wrong direction.It was found that the blue lines were misaligned.The cds was removed and reinserted without issue.At this point the implanted clip (b)(4) detached from the anterior leaflet, and remained attached to the posterior leaflet (single leaflet device attachment/slda).The physician believed that the slda was partly due to inadequate leaflet insertion, and the difficulty with the second clip.An attempt was made to place the new clip lateral to the first, but it was not possible to grasp both leaflets due to the abnormal movement of the posterior leaflet caused by the slda.The decision was made to place the clip more lateral and place an additional clip between the two clips.The clip was implanted successfully.A fourth cds was advanced, and the clip was implanted.Three clips were implanted, reducing the mr to 2.No additional information was provided.Concomitant products: mitraclip system, clip delivery system (x1), 1 implanted mitraclip.The three clip delivery systems referenced are filed under separate medwatch mfr numbers.The steerable guide catheter is expected to be returned for investigation.It has not yet been received.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 that after removal of the steerable guiding catheter (b)(4), severe damage (tear) was noted to the sgc tip.A torn soft tip has the remote potential to cause injury if a piece of the soft tip is left behind in the anatomy.This was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.Challenging anatomy was noted.The first clip delivery system (b)(4) was advanced.Leaflet grasping was performed and it was noted that the anterior leaflet was not well attached; however, the clip was deployed, reducing the mr to 3.The second cds (b)(4) was advanced to the left atrium.When the delivery catheter (dc) handle was advanced, the clip would dive in random directions.A little m knob was needed to obtain correct position over the jet, which was unusual.The cds began to be retracted, but resistance was noted with the steerable guiding catheter (b)(4), due to a kink proximal to the clip.The cds became stuck on the sgc tip approximately 5 times, and the devices were removed together.After removal, it was noted that the sgc was torn in several places.Both devices were replaced.Extended anesthesia was given due to the issue with the second cds.
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Manufacturer Narrative
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(b)(4).Evaluation summary: (b)(4).The complaint device was returned for evaluation.The reported tears of the guide soft tip material were confirmed via returned device analysis.The investigation concluded that the reported user experience was related to procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the information reviewed, 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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