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 06/08/2016 |
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 device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The mitraclip device referenced is being filed under a separate medwatch report.
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Event Description
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This event is filed for damage to the soft tip of the steerable guide catheter (sgc), which has the potential to cause or contribute to patient injury.It was reported that the patient, with functional mitral regurgitation, underwent a mitraclip procedure.The clip delivery system (cds) was advanced into the patient anatomy and although the knobs were not turned excessively, the device was noted to dive anteriorly and medially.A bend was noted in the shaft.The cds was removed, but the grippers of the clip caught on the soft tip of the sgc.The system, both cds and sgc, were removed to the right atrium and the clip was able to be freed from the sgc.A tear was noted in the soft tip, but the device remained intact.There was no adverse patient effect.The procedure continued using a second sgc and two clips were implanted, reducing the mr grade from 4+to 2+.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the complaint device was returned and evaluated.The reported steerable guide catheter (sgc) torn soft tip was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 related to procedural conditions.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Manufacturer Narrative
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(b)(4).The reported patient effects of hematoma and pain, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effects of hematoma, pain and swelling appear to be related to operational context of the procedure.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the initial 30-day and follow up #1 medwatch reports, additional information was received, which indicated that approximately 2 weeks post procedure, the patient experience severe pain and swelling at the access site, as well as some bruising.The pain was noted as radiating to the hip and down the leg.X-rays were obtained and the physician noted that the pain was likely sciatica.No additional intervention was performed and the patients pain and swelling resolved on (b)(6) 2016.No additional information was provided.
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Search Alerts/Recalls
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