Model Number VENUM14140 |
Device Problems
Misfire (2532); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will 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.(expiry date: 09/2022).
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Event Description
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It was reported that during a stent placement procedure through common femoral vein, the device allegedly had a partial deployment in the distal edge.There was no reported patient injury.
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Event Description
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It was reported that during stent placement in the iliac vein through femoral access, the distal portion of the stent failed to expand as the stent was being adhered to the deployment system.As reported, physician turned the deployment in a clockwise fashion until the catheter released itself from the stent, and then removed the deployment catheter from the body.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: the lot history record of this lot was 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: a physical sample was not available for evaluation and images have not been provided.Based on the information available the investigation is inconclusive for reported issue.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant instructions for use for this product was conducted.The instructions for use was found to address potential complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H10: d4 (expiry date: 09/2022), g3.H11: h6(device, result, conclusion).H11: section a through f ¿ the information provide 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.H3 other text : device not returned.
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Search Alerts/Recalls
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