Catalog Number M003EZAS45210 |
Device Problems
Premature Activation (1484); Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device is not available to manufacturer.
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Event Description
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It was reported that during the procedure, when the physician attempted to deploy the stent (subject device), it was not present in the shaft.The subject stent had prematurely detached during use.The procedure was not completed successfully as the physician was not able to place the subject stent inside the patient's anatomy.No clinical consequences were reported to the patient due to this event.No further information is available at the moment.
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Manufacturer Narrative
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B5 - executive summary: updated d4 expiration date - added h4 manufacturing date ¿ added due to the automated controls within the mes system it is not possible for the edhr of released product built using mes to contain any discrepancies that could have contributed to the reported event.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed and it cannot be determined that the device met specification upon release, as the device was not returned.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 analysed event.In the case of this complaint it is likely that the stent was deployed prematurely during unpacking of the device or during preparation, this however cannot be conclusively determined.During device manufacture components are electronically scanned to ensure the component is present as per nv00021039.In addition confirmation the stent is loaded is verified as per procedure nv00004165.While there are a number of potential causes for the reported issue, as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause, an assignable cause of undeterminable will be assigned to this complaint.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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Event Description
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It was reported that during the procedure, when the physician attempted to deploy the stent (subject device), it was not present in the shaft.The subject stent had prematurely detached during use.The procedure was not completed successfully as the physician was not able to place the subject stent inside the patient's anatomy.No clinical consequences were reported to the patient due to this event.No further information is available at the moment.Update: based on further review of the event on 14-jul-2020, the stent was missing from the shaft but did not deploy prematurely during the procedure inside the patient anatomy.
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Search Alerts/Recalls
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