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Catalog Number DL950F |
Device Problems
Difficult to Remove (1528); Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us, but is similar to the denali filter system products that are cleared in the us.The pro code and 510k number for the denali filter system products is identified in common device name and pma/510k.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not 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: 12/2024).
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Event Description
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It was reported that during a vena cava filter retrieval procedure, the filter was allegedly found to be tilted.It was further reported that the filter was allegedly unable to be removed.There was no reported patient injury.
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Event Description
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It was reported that during a vena cava filter retrieval procedure, the filter was allegedly found to be tilted.It was further reported that the filter was allegedly unable to be removed.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 denali filter system products that are cleared in the us.The pro code and 510k number for the denali filter system products is identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One image was reviewed.This shows a vena cava filter in place with the most proximal edge near the origin of the left renal vein.This is more proximal than the expected location below the origins of the renal veins.The filter is significantly tilted.Two catheters and sheaths are visualized above and below the filter, presumably from neck and groin access.The image clearly shows a tilted filter.Based on the image, the reported malposition of device issue can be confirmed as the filter was tilted.However, the investigation is inconclusive for retrieval difficulties as there is no evidence provided for this reported issue.A definitive root cause for the reported malposition of device and failure to remove issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 12/2024), g3, h6 (method).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.
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Manufacturer Narrative
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The catalog number identified in section d4 has not been cleared in the us, but is similar to the denali filter system products that are cleared in the us.The pro code and 510k number for the denali filter system products is identified in d2 and g4.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One image was reviewed.The image shows the filter which is significantly tilted.Two catheters and sheaths are visualized above and below the filter.Based on the image, the reported malposition of device issue can be confirmed as the filter was tilted.However, the investigation is inconclusive for retrieval difficulties as there is no evidence provided for this reported issue.Therefore, the investigation is confirmed for the reported malposition of device and inconclusive for failure to remove issue.A definitive root cause for the reported malposition of device and failure to remove issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 12/2024), g3.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.
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Event Description
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It was reported that during a vena cava filter retrieval procedure, the filter was allegedly found to be tilted.It was further reported that the filter was allegedly unable to be removed.There was no reported patient injury.
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Search Alerts/Recalls
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