Model Number 7880 |
Device Problems
Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event - event date was not reported and was approximated to (b)(6) 2021.
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Event Description
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It was reported that there was a hole in the catheter.A 5f impulse guide catheter with a pigtail curve was selected for use in a coronary angiography procedure.During the procedure inside the patient, the catheter kinked.This resulted in an extra hole in the catheter, which the guide wire went through repeatedly.Another of the same device was used to complete the procedure.No patient complications were reported.
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Event Description
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It was reported that there was a hole in the catheter.A 5f impulse guide catheter with a pigtail curve was selected for use in a coronary angiography procedure.During the procedure inside the patient, the catheter kinked.This resulted in an extra hole in the catheter, which the guide wire went through repeatedly.Another of the same device was used to complete the procedure.No patient complications were reported.It was further reported that the kink occurred in the pigtail curve.The carrier tube was hydrated prior to removing the device from the tube.A number of minutes elapsed between the hydration of the carrier tube and the removal of the device from the tube.
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Manufacturer Narrative
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B3: date of event - event date was not reported and was approximated to (b)(6) 2021.Device evaluated by mfr: returned product consisted of a 5f impulse diagnostic catheter.The device was bloody.Analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed a kink in the shaft located 8cm from the tip, and a hole was located at the site of the kink.The hole was pushed outward, indicating that something from the inside of the shaft perforated the shaft wall.Inspection of the rest of the device found no other damage or defect.
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Search Alerts/Recalls
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