Catalog Number UNK_NEU |
Device Problems
Expulsion (2933); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2022 |
Event Type
Injury
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Event Description
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It was reported that during stent assisted coiling procedure, physician attempted to put the last coil.He repositioned the coil two times, however the coil was unable to be advanced or retract as there was the subject coil tail remaining in the internal carotid artery (ica).Physician used a stent to pin the coil against the vessel wall.The additional stenting resulted in an hour procedural delay.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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The device is not available to the manufacturer.
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Event Description
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It was reported that during stent assisted coiling procedure, physician attempted to put the last coil.He repositioned the coil two times, however the coil was unable to be advanced or retract as there was the subject coil tail remaining in the internal carotid artery (ica).Physician used a stent to pin the coil against the vessel wall.The additional stenting resulted in an hour procedural delay.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Additional information received by the customer on 10-apr-2023 clarified that there was no allegation against the subject coil and the issue was against the last coil which is already reported.
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Manufacturer Narrative
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This is 2 of 2 mdrs (2nd report).Section b1 adverse event/product problem - corrected ¿ no adverse event and product problem.Section b2 outcomes attributed to ae ¿ corrected ¿ no required intervention to prevent permanent impairment/damage (devices).Section h1 type of reportable event - corrected - no serious injury.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.There was no allegation of failure or malfunction against this device, therefore a labelling review and a risk analysis could not be performed.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, a cause of undeterminable was assigned to the as reported.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
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Search Alerts/Recalls
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