CARDINAL HEALTH MEXICO OPTEASE RETR FILTER 55 FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number 466F210AF |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information is pending and will be sent in upon 30 days after receipt.
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Event Description
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As reported that when advancing the sheath, the 55cm femoral optease retrievable vena cava punctured it and it could not continue to push.There was no reported patient injury.The device was stored in the cath lab for two weeks.The device was stored, handled, and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no anomaly noted prior to inserting into the patient.There was no damage to the device noticed prior to opening the package.There was no unusual force used at any time during the procedure.There was no difficulty removing the device from the sterile packaging.The target lesion was postcava.The lesion was not calcified and there was no vessel tortuosity.The device was not used for a chronic total occlusion.The procedure was completed using another optease.The device will be returned for evaluation.
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Manufacturer Narrative
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After further review of additional information received the following sections g3, g6, h2 and h6 have been updated accordingly.When advancing the sheath, the 55cm optease retrievable filter punctured it and it could not continue to push.There was no reported patient injury.The device was stored in the cath lab for two weeks.The device was stored, handled, and prepped per the instructions for use (ifu).There was no difficulty when prepping the device.There was no anomaly noted prior to inserting into the patient.There was no damage to the device noticed prior to opening the package.There was no unusual force used at any time during the procedure.There was no difficulty removing the device from the sterile packaging.The target lesion was postcava.The lesion was not calcified and there was no vessel tortuosity.The device was not used for a chronic total occlusion.The procedure was completed using another optease retrievable filter.The device was not returned for analysis.A product history record (phr) review of lot 17940877 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter impeded - perforated sheath¿ could not be confirmed since the device was not returned for analysis.Procedural and/or handling factors, such as operator technique, could have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
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Manufacturer Narrative
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The device has been returned for evaluation, but the manufacture report is not yet available.Additional information is pending and will be sent in upon 30 days after receipt.
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Manufacturer Narrative
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When advancing the sheath, the 55cm optease retrievable filter punctured it and it could not continue to push.There was no reported patient injury.The device was stored in the cath lab for two weeks.The device was stored, handled, and prepped per the instructions for use (ifu).There was no difficulty when prepping the device.There was no anomaly noted prior to inserting into the patient.There was no damage to the device noticed prior to opening the package.There was no unusual force used at any time during the procedure.There was no difficulty removing the device from the sterile packaging.The target lesion was postcava.The lesion was not calcified and there was no vessel tortuosity.The device was not used for a chronic total occlusion.The procedure was completed using another optease retrievable filter.The device was returned for evaluation.Per visual analysis, the obturator, the filter, and the vessel dilator that was already inserted on the sheath, were returned.No anomalies were noted at naked eye.The filter had dry blood residues indicating it was already used.Per microscopic analysis, amplified images were taken for a better observation of the sheath and a perforated condition was found.The type of damage present on the cannula is commonly caused during the interaction of the cannula material with a sharp object or mechanical damage.It appears that the cannula material was punctured with a sharp object from the inside of the cannula.In this case the barbs of the filter, since plastic material like the plastic on the sheath was found, that could probably lead to the perforated condition found on the received component.Additionally, the filter was reviewed under a vision system, with special attention given to the barbs and no anomalies were found.A product history record (phr) review of lot 17940877 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter ¿ impeded - perforated sheath¿ was confirmed since a perforated condition was found on the cannula during analysis.However, the exact cause of the reported event could not be conclusively determined.Procedural and/or handling factors, such as operator technique, may have contributed to the reported condition on the device since it did not present any obvious indication of manufacturing defect or anomaly that could have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
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