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Catalog Number FEM10080 |
Device Problems
Break (1069); Misfire (2532)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during a stent placement procedure in the arteriovenous fistula, there was slight resistance during the stent graft deployment attempt, and the stent would not fully deploy.It was further reported that fifty to sixty percent of the stent graft got deployed.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the stent delivery system was not returned for evaluation and photos were not provided for review which leads to inconclusive results.It was reported that resistance was felt during deployment and the sheath fractured.Based on the provided information and as the sample was not returned for evaluation, the investigation is closed with inconclusive results.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instructions for use state: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' regarding preparation of the device the instructions for use state that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment".Regarding the anatomy of the placement site the instructions for use states: "prior to stent graft deployment, ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy".Regarding accessories the instructions for use states: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.H11: the initial mdr was inadvertently submitted with a g3 date of 08/09/2023.The correct g3 date is 08/10/2023.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during a stent placement procedure in the arteriovenous fistula, there was slight resistance during the stent graft deployment attempt, and the stent would not fully deploy.It was further reported that fifty to sixty percent of the stent graft got deployed.Reportedly, the catheter was allegedly fractured.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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