Catalog Number M0035442040 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2023 |
Event Type
Injury
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Event Description
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It was reported that during the procedure, the subject coil was detached but the proximal end was caught on the tip of the microcatheter.An additional device was used as a medical intervention to force the subject coil off the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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Manufacturer Narrative
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H3 other text : the device remains implanted inside the patient's vasculature.
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Manufacturer Narrative
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Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 and the device was not returned, an assignable cause of undeterminable was assigned to the complaint of patient medical or surgical intervention required and deice interaction with another device.
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Event Description
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It was reported that during the procedure, the subject coil was detached but the proximal end was caught on the tip of the microcatheter.An additional device was used as a medical intervention to force the subject coil off the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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Search Alerts/Recalls
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