Catalog Number FVL09040 |
Device Problems
Positioning Failure (1158); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a stent graft placement procedure in cephalic vein outflow of brachiocephalic fistulae, when tried to deploy the stent, the stent allegedly did not open.Reportedly, the stent was removed, and procedure was completed by using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025).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 pending return.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.H10: d4 (expiry date: 05/2025), g3.H11: h6 (device).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 pending return.
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Event Description
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It was reported that during a stent graft placement procedure in cephalic vein outflow of brachiocephalic fistulae, when tried to deploy the stent, the stent allegedly did not open.Reportedly, the stent was removed, and procedure was completed by using another device.There was no reported patient injury.
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Search Alerts/Recalls
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