Model Number 7840 |
Device Problems
Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2023 |
Event Type
malfunction
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Event Description
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It was reported that foreign matter was present in the device lumen.A5f expo fl3.5 diagnostic catheter was selected for use.A 0.035-inch non-boston scientific (non-bsc) wire was introduced through the catheter outside the patient, but the wire would not advance near the first and second device curves.When more effort was applied, suddenly the wire advanced out the tip of the expo catheter and a large white chunk of plastic debris exited the catheter.The same thing occurred with a 5f expo fl4 diagnostic catheter.The procedure was completed using an alternate method and there were no patient complications.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.During visual inspection no damage or defect was observed.An examination of the device x-ray found evidence of inner liner delamination.A 0.35-inch test guidewire was inserted in the distal tip end and met resistance.The wire was inserted in the hub end and met resistance in the same location.Inspection under the microscope revealed inner liner delamination 6cm proximal of the tip to where a section of the liner came out.Fourier-transform infrared spectroscopy (ftir) was performed to identify a piece returned separately and confirmed it to be consistent with the inner liner material.A review of the photo provided by the site showed a piece of the inner liner separated from the catheter, confirming the reported event.
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Event Description
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It was reported that foreign matter was present in the device lumen.A5f expo fl3.5 diagnostic catheter was selected for use.A 0.035-inch non-boston scientific (non-bsc) wire was introduced through the catheter outside the patient, but the wire would not advance near the first and second device curves.When more effort was applied, suddenly the wire advanced out the tip of the expo catheter and a large white chunk of plastic debris exited the catheter.The same thing occurred with a 5f expo fl4 diagnostic catheter.The procedure was completed using an alternate method and there were no patient complications.
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Search Alerts/Recalls
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