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Catalog Number RF400F |
Device Problems
Patient-Device Incompatibility (2682); Extrusion (2934); Patient Device Interaction Problem (4001)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with lower extremity fractures and solid organ injuries sustained from a motor vehicle accident had a vena cava filter deployed without incident.The patient tolerated the procedure well, there were no complications.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive for perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 03/2013); (manufacturing date: 03/2010).The information provided by bard represents all of 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 bard.
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Event Description
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before an orthopedic procedure and in conjunction with a trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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Event Description
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before an orthopedic procedure and in conjunction with a trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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Manufacturer Narrative
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The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with lower extremity fractures and solid organ injuries sustained from a motor vehicle accident had a vena cava filter deployed without incident.The patient tolerated the procedure well, there were no complications.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive for perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 03/2013), (manufacturing date: 03/2010).
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Event Description
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before an orthopedic procedure and in conjunction with a trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately four years and ten months of post deployment, computerized tomography-abdomen/pelvis was performed which showed that an inferior vena cava filter was in l1-2 interspace to sup l3.Positive for grade 3 perforation, that right lateral struts abutting duodenum.There was no migration and coronal tilt.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc).Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: (expiry date: 03/2013).H11:section a through f - the information provided by bd represents all of 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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