Catalog Number UNK_NEU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fistula (1862)
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Event Date 06/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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This is first of 2 reports.The subject device is unavailable to manufacturer.
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Event Description
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It was reported that during study procedure, the subject device distal access catheter along with other device (balloon guide catheter) were used to remove a clot from the left m1 middle cerebral artery (mca) femoral artery.The patient developed caroticocavernous fistula.However, the physician did not administer any treatment in response to the event and the event was resolved without any clinical consequences to the patient.It¿s indicated that the relationship of the event to the subject device and index procedure.No further information provided.
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Manufacturer Narrative
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Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that the subject catheter was confirmed to be in good condition post unpacking and preparation and it was prepared as per dfu.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported.
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Event Description
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It was reported that during study procedure, the subject device distal access catheter along with other device (balloon guide catheter) were used to remove a clot from the left m1 middle cerebral artery (mca) femoral artery.The patient developed caroticocavernous fistula.However, the physician did not administer any treatment in response to the event and the event was resolved without any clinical consequences to the patient.It¿s indicated that the relationship of the event to the subject device and index procedure.No further information provided.Updated additional information: additional information received on 22-july-2020 stated that the subject device distal access catheter was used to access on the right femoral artery and the cause of the caroticocavernous fistula was a tear in the carotid artery by the catalyst (is being pulled up when the thrombectomy is performed).
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Search Alerts/Recalls
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