Model Number MV-A6125ST |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for evaluation; however, one fluoroscopic image was provided and reviewed.The image demonstrates an implanted stent with a wire visible in the proximal to middle segment of the stent.The distal tip of the wire appears to be prolapsed and positioned against the wall of the stent in the mid-section.The sofia catheter does not appear in this image.No real-time dynamic/fluoroscopic images were provided.
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Event Description
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It was reported that aspiration thrombectomy was performed for an in-stent thrombosis.During placement of the catheter, the guide wire became stuck between the sofiaflow and the implanted stent.The guide wire was retracted with force and removed.The sofiaflow then successfully aspirated the blood clot after two passes and was removed from the patient through the balloon guiding catheter.Upon removal, the collected blood clot was examined and a piece of clear vinyl was found.The sofiaflow was checked and a 0.8mm portion of the distal catheter tip was missing.There was no reported patient injury or clinical sequela.
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Manufacturer Narrative
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The device was received for evaluation along with a petri dish with a vinyl substance in a gauze pad.The returned sofia was inspected.The catheter tip was observed to be damaged and folded in and no piece appeared to be missing.The returned unknown material was inspected and determined not to be from the sofia inner liner.The substance was sent out for fourier-transform infrared spectroscopy (ftir) analysis and the result of the analysis showed that the material was a piece of polyester film, which was not part of the polyethylene inner layer of the sofia; it does not appear that the material originated from the sofia device.Testing of the returned sofia found that the catheter could be tracked with a wire and flushed without resistance.The investigation of the returned sofia found the distal tip to be damaged, but no section was missing as described in the complaint.A piece of unknown material was returned for evaluation; the visual analysis of the substance determined that it did not originate from the sofia's inner liner, but the material could not be definitively identified; the material was sent out for fourier-transform infrared spectroscopy (ftir) analysis to determine what the material was.Ftir determined the substance to be a piece of polyester film, which did not originate from the sofia.H11: (e1) correction: country.
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Manufacturer Narrative
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The polymeric material of unknown origin did not originate from the sofia device.The ftir spectral analysis of the polymeric material of unknown origin does, however, resemble a pet masking that is used during the manufacture of the device.However, it cannot be definitively concluded as the source of the polymeric material of unknown origin.The complaint report indicated other concomitant devices such as a wall stent being used which have polymeric materials as part of their delivery systems.
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Search Alerts/Recalls
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