Model Number 39540 |
Device Problem
Material Perforation (2205)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2020 |
Event Type
malfunction
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Event Description
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It was reported that a catheter perforation occurred.The target lesion was located in the moderately tortuous and moderately calcified right iliac arterial stent and left angiogram.A 90cm rubicon 18 guide catheter was selected for use.During the procedure, after removal of the device from the patient's body, it was discovered that the wire inside the catheter penetrated through the rubicon catheter.The wire was visibly out of the catheter.The procedure was completed using multiple catheters of various types.No complications were reported and the patient was fine post procedure.
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Event Description
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It was reported that a catheter perforation occurred.The target lesion was located in the moderately tortuous and moderately calcified right iliac arterial stent and left angiogram.A 90cm rubicon 18 guide catheter was selected for use.During the procedure, after removal of the device from the patient's body, it was discovered that the wire inside the catheter penetrated through the rubicon catheter.The wire was visibly out of the catheter.The procedure was completed using multiple catheters of various types.No complications were reported and the patient was fine post procedure.It was further reported that a 90cm rubicon 35 guide catheter was selected for use.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.There was blood and contrast in the device.Analysis of the tip, shaft, and hub relief included microscopic and visual inspection.Inspection revealed a shaft kink located 5.9cm from the tip, and shaft damage (hole/perforation) located 10.2cm from the tip.Inspection of the rest of the device found no other damage or defect.The reported shaft perforation was confirmed.
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Event Description
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It was reported that a catheter perforation occurred.The target lesion was located in the moderately tortuous and moderately calcified right iliac arterial stent and left angiogram.A 90cm rubicon 18 guide catheter was selected for use.During the procedure, after removal of the device from the patient's body, it was discovered that the wire inside the catheter penetrated through the rubicon catheter.The wire was visibly out of the catheter.The procedure was completed using multiple catheters of various types.No complications were reported and the patient was fine post procedure.It was further reported that a 90cm rubicon 35 guide catheter was selected for use.
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Search Alerts/Recalls
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