Model Number VENUM14160 |
Device Problems
Difficult or Delayed Positioning (1157); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation; however, a image was provided for review.The investigation of the reported event is currently underway.Expiry date (08/2022).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.
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Event Description
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It was reported that during a stent placement, the device allegedly had difficulty to deploy and failed to expand in the distal part.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: the sample was returned for evaluation.The condition of the returned delivery system confirmed the alleged expansion issue.The silicone brake of the inner catheter, which was under the stent, was found shifted to distal which indicated that the stent adhered to the brake leading to breakaway and shifting upon removal.One image was provided demonstrating the placed stent inside the vessel.The stent was visibly constricted in the area of the silicone stent brake.Distal and proximal of that section the stent was regularly expanded so that it appeared like an hour-glass which indicated that the deployment sheath was retracted and that the stent adhered to the silicone brake, which leads to a confirmed result for expansion issue.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant for this product was conducted.The instruction 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: (expiry date: 08/2022).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 : see h10.
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Event Description
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It was reported that during a stent placement, the device allegedly had difficulty to deploy and failed to expand in the distal part.There was no reported patient injury.
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Search Alerts/Recalls
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