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Catalog Number FEM10100 |
Device Problems
Fracture (1260); Misfire (2532)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2023 |
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 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 graft placement procedure, the stent allegedly partially deployed.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: 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 which leads to inconclusive results.It was reported that a 7fr was used for access but the stent was deployed without sheath, the tracking vessel was not tortuous and did not appear calcified, the lesion was pre-dilated and the device was flushed before use.Based on the provided information and as the sample was not provided for evaluation, the investigation is closed with inconclusive results for partial deployment.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 (ifu) sufficiently address the potential risks.The instruction 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 instruction 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 instruction 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 instruction 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".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.Device not returned.
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Event Description
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It was reported that during a stent graft placement procedure in the left cephalic arch via the left upper arm, the stent allegedly partially deployed.The procedure was completed using another device.There was no reported patient injury.
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Event Description
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It was reported that during a stent graft placement procedure in left upper arm cephalic arch to treat some residual stenosis, the stent graft allegedly partially deployed.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the stent delivery system was returned for evaluation; the stent graft was found partially deployed and the outer sheath was fractured which leads to confirmed results for partial deployment and sheath fracture.It was reported that a 7fr introducer was used for access but the procedure was sheathless, the tracking vessel was not tortuous and did not appear calcified, the lesion was pre-dilated and the device was flushed before use.Based on provided information and returned sample evaluation, the investigation is closed with confirmed results for partial deployment and sheath fracture.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 instruction 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 instruction 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 instruction 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 ifu 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 9f and a 0.035" guidewire.H10: b5, d4 (expiry date: 03/2026), g3, h2, h6 (device).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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Search Alerts/Recalls
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