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Model Number 466F210A |
Device Problems
Difficult to Insert (1316); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
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Event Description
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As reported, the 55 optease retrievable filter was pushed into the ¿delivery rod¿ and cannot be released.The malfunction occurred during use.There was no reported patient injury.The filter was placed post cava, for pulmonary embolism (pe) prevention.The lesion had no calcification, no vessel tortuosity, no angulation, and no stenosis.The device was stored and handled according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.The device was prepped per the ifu and prepped normally.There were no kinks or other damages noted prior to inserting the product into the patient.The insertion difficulty was not caused by a blockage of possibly injectable material.There was no unusual force used at any time during the procedure.The malfunction required that all the concomitant products be removed together.The device was easily removed from the patient intact (in one piece).As per product analysis, a filter barb was observed piercing the cannula from the inside, preventing the filter to deploy.Nevertheless, functional test was performed successfully; the filter was deployed successfully.A puncture/hole was observed on the cannula once the filter was deployed.Per microscopic analysis of the puncture/hole observed on the cannula, sem results showed that the inner surface of the cannula presented scratch marks and bulged/peeled off material near the puncture/hole.This type of damage is commonly caused during the interaction of the cannula material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and bulged/peeled off material on the cannula surfaces could probably led to the punctured condition found on the received cannula.It seems the cannula material was punctured with a sharp object from the inside of the cannula.The cause of the filter barb piercing the cannula could not be conclusively determined during the analysis.The filter was revised under vision system, especial attention was given to the barbs, but no anomalies were found.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 have been updated accordingly g4,g6,h1,h2,h3 and h6.The 55 optease retrievable filter was pushed into the ¿delivery rod¿ and cannot be released.The malfunction occurred during use.There was no reported patient injury.The filter was placed post cava, for pulmonary embolism (pe) prevention.The lesion had no calcification, no vessel tortuosity, no angulation, and no stenosis.The device was stored and handled according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.The device was prepped per the ifu and prepped normally.There were no kinks or other damages noted prior to inserting the product into the patient.The insertion difficulty was not caused by a blockage of possibly injectable material.There was no unusual force used at any time during the procedure.The malfunction required that all the concomitant products be removed together.The device was easily removed from the patient intact.The product was returned for analysis.Per visual analysis, a filter barb was observed piercing the cannula from the inside, preventing the filter from deployment.No other anomalies were observed on the unit.Per functional analysis, a functional test was performed successfully.Filter was deployed successfully.No anomalies were observed on the filter.A puncture/hole was observed on the cannula once the filter was deployed.Per microscopic analysis of the puncture/hole observed on the cannula, the outer surface of the cannula presented bulged/peeled off material along the puncture/hole.The inner surface presented evidence of scratch marks and bulged/peeled off material near the puncture/hole.This type of damage is commonly caused during the interaction of the cannula material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and bulged/peeled off material on the cannula inner surface could have likely led to the punctured condition found on the received cannula.It appears that the cannula material was punctured with a sharp object from the inside of the cannula.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17939408 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer (csi)¿ obstructed¿ and ¿filter ¿ impeded-perforated sheath¿ were confirmed through analysis of the returned device.The exact cause of the reported events could not be conclusively determined.Based on the information available for review, procedural factors, such as operator technique, may have contributed to the 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 product analysis available suggests that the event reported by the customer could be related to the design or the manufacturing process; therefore, no corrective/preventive actions will be taken at this time.
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Search Alerts/Recalls
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