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Model Number N/A |
Device Problems
Difficult to Insert (1316); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Impedance Problem (2950); Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2022 |
Event Type
malfunction
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Event Description
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As reported, an optease retrievable filter 55 was punctured from the sheath when it was loaded into the sheath during a femoral vein approach.Adequate flush maintained throughout the procedure.Excessive force was not used.The procedure was completed by switching to another device.There was no reported patient injury.Image review depicts a white catheter with what appears to be a puncture cut in the side wall of the catheter.A second image depicts a cordis optease filter catheter.Again, a puncture/cut can be visualized in the wall of the catheter.Additionally, the catheter is separated in 2 pieces distally to the puncture.The separation is clean and even as though it was severed with a sharp instrument.The device will be returned for evaluation.
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Manufacturer Narrative
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(b)(4).Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.
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Event Description
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As reported, an optease retrievable filter 55 was punctured from the sheath when it was loaded into the sheath.There was no reported patient injury.Image review depicts a white catheter with what appears to be a puncture cut in the side wall of the catheter.A second image depicts a cordis optease filter catheter.Again, a puncture/cut can be visualized in the wall of the catheter.Additionally, the catheter is separated in 2 pieces distally to the puncture.The separation is clean and even as though it was severed with a sharp instrument.The device was later returned for evaluation.
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Manufacturer Narrative
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As reported, an optease retrievable filter 55 was punctured from the sheath when it was loaded into the sheath.There was no reported patient injury.Image review depicts a white catheter with what appears to be a puncture cut in the side wall of the catheter.A second image depicts a cordis optease filter catheter.Again, a puncture/cut can be visualized in the wall of the catheter.Additionally, the catheter is separated in 2 pieces distally to the puncture.The separation is clean and even as though it was severed with a sharp instrument.Initially 2 images were provided.Per visual analysis of the image 1, a 6f csi was observed punctured by a filter.A separation of the cannula was also noted.The second image shows a close up of the csi punctured area.The device was subsequently returned for analysis.A non-sterile unit of ¿optease retr filter 55 femoral¿ was received inside of a clear plastic bag.The parts included on the shipment are two brite tip csi, and the filter loaded inside the cannula of one the returned brite tip csi.All components were thoroughly inspected observing that one of the brite tip csi presents a separated condition located approximately at 22 cm from the distal tip, a perforated condition at 27.5 cm from the distal tip, and the filter is inside located at 28 cm from the distal tip.The other brite tip csi does not present any damages or anomalies.Dimensional analysis was performed to verify the correct outer diameter (od) and inner diameter (id) of the cannula, near the separation edge.Results were found within specification.Per functional analysis, the filter was withdrawn from the separated bts csi and was introduced into a one lab sample winged storage tube.The lab sample winged storage tube with the returned filter inside was inserted as far as possible into the hub of the returned bts csi that presented no damages or anomalies.One lab sample obturator was inserted through the proximal end of the winged storage tube.The filter was advanced through the bts csi pushing with the lab sample obturator.The obturator was advanced through the bts csi until the filter got out through the distal end.No resistance or obstruction was noticed.The filter was evaluated with a vision system to obtain a magnify image.Neither the filter barbs nor the rest of the part present any damages or anomalies.Sem results showed that the separated area and the puncture/cut area on the cannula of the optease retr filter 55 device presented evidence of scratch marks near the damaged are on the inner surface of the component.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.No other anomalies were observed during the sem analysis.A product history review of lot 18033365 revealed no anomalies during the manufacturing and inspection processes that can be considered potentially related to the reported complaint.The reported ¿filter ¿ impeded - perforated sheath¿ and catheter sheath introducer (csi) t -separated¿ was confirmed during analysis of the returned device.The exact cause for the events could not conclusively be determined.There are procedural and handling factors that may 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 following sections have been updated accordingly: d8/d9, g3, g6, h1 and h2.Additional information is pending and will be submitted within 30 days of receipt.
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Search Alerts/Recalls
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