|
Catalog Number MD800F |
Device Problems
Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
|
Patient Problem
Pain (1994)
|
Event Date 06/29/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the alleged 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.
|
|
Event Description
|
It was reported through the litigation process that the filter perforated greater than three-and-one-half millimeters outside the inferior vena cava.The patient reportedly experienced pain; however, the current status of the patient is unknown.
|
|
Event Description
|
It was reported through the litigation process that the filter perforated greater than three-and-one-half millimeters outside the inferior vena cava.The patient reportedly experienced pain; however, the current status of the patient is unknown.
|
|
Manufacturer Narrative
|
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 eight months post filter deployment, computed tomography revealed that caval perforation was noted at 5 o¿clock 3.6 mm.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).Based on 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: 06/014.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.
|
|
Search Alerts/Recalls
|
|
|